#clinical trials in australia guidelines

[ccrpsorg]

2023 Updates for Clinical Research Associates and Clinical Research Monitors

Common clinical trial guidelines used for monitors are designed to ensure the safety and accuracy of the data collected. These guidelines help to make sure that all participants in the trial are treated fairly and ethically, as well as ensuring that the results of the trial will be useful for medical research.

One important guideline is that the monitor must be independent from both the sponsor and investigator. The monitor should have no interest in or influence on the study's outcome, and must have complete access to any documents or records related to conducting the trial. Additionally, they are responsible for ensuring that all protocols are followed correctly, data is correctly recorded and stored, and any adverse events or reactions reported accurately and promptly.

Another key guideline is that monitors must act in accordance with Good Clinical Practice (GCP) guidelines established by International Conference on Harmonization (ICH). GCP outlines procedures for clinical trials involving human subjects so that ethical practices can be maintained throughout a study. It covers many topics including informed consent, protocol review, quality assurance/monitoring, investigator qualification requirements, patient safety procedures, and data verification methods.

Additionally, monitors may use other standards such as The Code of Federal Regulations (CFR), which is used by US Food & Drug Administration (FDA) to regulate drugs; International Committee on Harmonization (ICH) E6R2 ethical guidelines; European Medicines Agency’s Guidelines on Good Clinical Practice (GCP); World Health Organization’s International Ethical Guidelines for Biomedical Research Involving Human Subjects; or local regulations specified by each country’s health ministry.

Overall, these guidelines help to ensure that monitors remain impartial during a clinical trial - this helps to protect participant safety as well as providing reliable data for researchers later down the line.

Clinical research monitors are responsible for ensuring the safety of participants in clinical trials and the accuracy of data collected. In 2023, there have been several updates to guidelines for clinical research monitors that they should be aware of.

The United States Food and Drug Administration (FDA) has released Clinical Trials Guidance Documents that provide advice on the conduct of clinical trials, good clinical practice, and human subject protection. These documents outline the standards that must be met in order to ensure a safe and ethical trial environment.

Clinical research associates (CRAs) play a key role in medical research, ensuring that clinical trials are conducted according to the highest standards of quality, safety and ethics. In light of this importance, the U.S. Food and Drug Administration (FDA) has recently released new guidelines for CRAs conducting clinical trials. These guidelines provide an important framework to ensure that all research is conducted responsibly and ethically while protecting participants’ rights and safety. The FDA’s new guidelines focus on three main areas: data security, participant monitoring protocol, and communication with sponsors.

First, the FDA has established stringent data security measures to protect trial participants’ information during all stages of the trial process. This includes measures such as encryption of sensitive data, physical access control systems for secure areas where information is stored or processed, and regular backups of critical data sets to prevent any potential losses due to cyber-attacks or system malfunctions.

Second, the FDA requires that participation by CRAs in clinical trials include appropriate monitoring protocols designed to minimize risks associated with various trial procedures. This may include frequent communication with study sponsors about changes in protocol or patient status; close observation of trial participants; review and approval of all research documents before their use; scheduling regular safety assessments; and maintaining accurate records of all activities associated with each trial phase.

Finally, CRAs must maintain open communication channels with sponsors throughout the duration of a clinical trial in order to promptly report any changes in protocol or patient status that may require further review or approval from sponsors. Additionally, CRAs need to be trained on how to effectively communicate any necessary updates or potential issues related to regulatory compliance so they can ensure effective oversight over the entire course of a study period.

The FDA's new clinical trial guidelines provide an essential reference point for CRAs responsible for conducting medical research safely and ethically while protecting participants' rights and well-being. With these comprehensive guidelines in place, CRAs now have an even greater responsibility than ever when it comes to ensuring the success of health-related studies around the world.

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers 3/15/2023

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products 1/31/2023

Clinical Investigator Administrative Actions — Disqualification 12/01/2022

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment 10/17/2022

Tissue Agnostic Drug Development in Oncology 10/17/2022

Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials 10/17/2022

Ethical Considerations for Clinical Investigations of Medical Products Involving Children 09/23/2022

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products 09/08/2022

We must always review the Handbook for Good Clinical Research Practice (GCP), which provides guidance on implementation of GCP standards. Additionally, the International Council for Harmonisation (ICH) has published Efficacy Guidelines which address design, conduct, safety and reporting of clinical trials.

2023 Good Clinical Practice Guidelines for Clinical Research Associates:

Clinical research associates must stay up-to-date on the latest clinical research regulations, guidance documents, and technology advancements in order to ensure ethical and compliant clinical trial management.

Clinical research associates must establish effective communication with all members of the research team to facilitate the exchange of information regarding study updates, timelines, and protocols.

Clinical research associates are responsible for performing accurate data entry into relevant databases or case report forms (CRFs) as part of their role in documenting results from clinical trials.

Clinical research associates must ensure that informed consent is obtained from all participants in accordance with local regulations and international ethical standards.

Clinical research associates must be knowledgeable about relevant In Vitro Diagnostic (IVD) device regulations and requirements for providing evidence of conformity, accuracy, and effectiveness prior to use in a study.

Clinical research associates should create detailed visit plans for each participant in order to maximize the efficiency of visits to investigator sites during a study without compromising data quality or patient safety.

Clinical research associates should conduct regular quality assurance (QA) activities such as source document verification (SDV), query resolution, audit trails, monitoring reports review, reconciliation activities etc., ensuring data accuracy throughout the course of a study period.

During audits or inspections conducted by regulatory authorities or ethics committees, clinical research associates must be prepared to present comprehensive documentation demonstrating compliance with GCP principles and local regulations governing clinical trial conduct.

The European Medicines Agency (EMA) has also released a Clinical Trials Regulation which harmonises processes for assessment and supervision of clinical trials throughout the EU. This regulation outlines requirements to ensure patient safety during a trial as well as evaluation procedures for new drugs or treatments being tested in a trial setting. Finally, The EQUATOR Network provides study protocols such as SPIRIT and PRISMA-P; diagnostic/prognostic studies such as STARD and TRIPOD; case reports such as CARE; extensions; clinical practice guidelines such as AGREE; all aimed at enhancing quality and transparency in health research publications.

In 2022, the US Food and Drug Administration (FDA) released new clinical trial guidelines that emphasize patient safety. The guidelines mandate that all clinical trials must adhere to a rigorous set of standards in order to ensure patient safety and efficacy.

The new guidelines require research teams to obtain written informed consent from participants prior to initiating any study activity. Abuse of animals is prohibited, and investigators are expected to use only those treatments that have shown potential benefit in animal studies. Additionally, researchers must report any adverse events or reactions during the course of the trial and ensure proper follow up care for affected individuals.

Furthermore, the FDA requires that research teams perform rigorous safety monitoring throughout the course of the trial. Regular data analyses and reviews must be conducted to identify potential risks and unexpected results, which must be reported in real time. Additionally, the FDA requires research teams to implement a system for tracking participant adherence to protocols, including collecting data on missed doses, changes in medication regimens, and other protocol violations.

The FDA also mandates more frequent reporting of results throughout the course of clinical trials. They require researchers to share interim results with stakeholders every six months or whenever significant changes occur in study design or purpose. These reports should include key findings as well as basic information about participant demographics and outcomes associated with each treatment arm.

Finally, the FDA has increased their emphasis on transparency by requiring researchers to disclose detailed information regarding sponsoring organizations and conflicts of interest associated with each study before it begins. This includes information related to payments made by sponsors as well as nonmonetary benefits received by investigators or other individuals associated with the trial.

By 2023, additional provisions will be added to these regulations including enhanced requirements related to diversity among participants; strengthened criteria for evaluating ethical considerations such as protection from harm; expanded definitions related to economic conflict-of-interest disclosure; greater emphasis on appropriate risk/benefit ratios; improved reporting of results utilizing standardized metrics; increased focus on study protocol adherence; enhanced data sharing practices; clear criteria for determining when further review is needed due health concerns; specified mechanisms for measuring patient quality-of-life outcomes; increased accountability through stronger recordkeeping systems; enhanced guidance around informed consent forms; improved methods for monitoring compliance; greater attention paid towards reviewing unpublished manuscripts related to clinical trials; expansion of proposed preventative measures targeting financial misconduct issues such as fraud detection systems; improved oversight mechanisms using Artificial Intelligence technologies such as natural language processing (NLP); and additional efforts aimed at improving public understanding around clinical trials through better communication strategies between sponsors and patients alike.

Stay up to date on clinical trials and your annual ICH GCP certification through one of the most comprehensive courses in the industry.

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[regulatorysolutionsindia]

CDSCO Approval Process for Medical Devices without Predicate

Introduction:

The landscape of the Indian medical device market is rapidly evolving, with current estimates placing its size at $11 billion, expected to surge to $50 billion by 2025. This growth presents a golden opportunity for manufacturers and importers to introduce their medical devices into India. However, for devices without a predicate, the regulatory approval pathway can be complex. In this blog, we’ll navigate through the process of obtaining approvals for such devices.

Firstly, let’s clarify what we mean by a “medical device without a predicate.” A predicate device, as defined by the Medical Device Rules (MDR) 2017, is one that shares similar intended use, material of construction, and design characteristics with a device already approved by the Central Licensing Authority. Thus, a medical device without a predicate lacks a comparable counterpart under the MDR 2017.

The regulatory pathway for obtaining approval for such devices involves several steps:

1. Clinical Investigation: Manufacturers/importers must conduct clinical investigations to establish safety and efficacy, adhering to guidelines set by India’s Central Drugs Standard Control Organization (CDSCO). Application submission occurs through Form MD-22, with approval granted in MD-23. However, exceptions to clinical investigation requirements exist, as detailed below.

2. Clinical Investigation Exceptions for Class B, C & D: Chapter VIII of the MDR 2017 outlines scenarios where clinical investigation submissions may be waived, such as if the device is approved by regulatory authorities in select countries (UK, USA, Australia, Canada, Japan) and has been on the market for at least two years, among other conditions.

3. Test License & Clinical Investigation Commencement: Following approval, obtain a test license (MD-13 for manufacturing or MD-17 for import) and proceed with clinical investigations.

4. Application for Approval of Medical Device without Predicate: Submit Form-26 for approval, receiving permission in Form MD-27, subject to conditions outlined in Chapter VIII of the MDR 2017.

5. Application for Import/Manufacturing License: Subsequent to MD-27, apply for the import license (MD-14/MD-3/7), submitting necessary documents.

For conducting clinical trials, follow these steps:

1. Identify an Indian Clinical Research Organization (CRO): Select an Indian CRO to manage and oversee clinical trials.

2. Submit Form MD-22 for Clinical Trial Permission: Prepare and submit Form MD-22 with supporting documents to CDSCO, requesting permission.

3. Grant of ‘Permission to Conduct Trials’: Upon review, CDSCO grants ‘Permission to Conduct Trials’ in Form MD-23.

4. Commence Clinical Trials After Approvals: After obtaining approvals and registrations, commence clinical trials.

Conclusion:

Introducing a medical device without a predicate into India’s market offers substantial opportunities but involves regulatory complexities. By meticulously following the approval roadmap and securing necessary permissions, manufacturers/importers can unlock significant benefits. Additionally, partnering with experienced entities like Regulatory Solutions India (RSI) can streamline the approval process, facilitating successful market entry. For more information or assistance, reach out to RSI today.

[jcmarchi]

“Unclear” Whether Opioids Are Effective At Treating Cancer Pain - Technology Org

New Post has been published on https://thedigitalinsider.com/unclear-whether-opioids-are-effective-at-treating-cancer-pain-technology-org/

“Unclear” Whether Opioids Are Effective At Treating Cancer Pain - Technology Org

The world’s largest review on opioid medicines for cancer pain has found it is unclear whether some commonly used opioid medicines are better than a placebo and suggests that non-opioid medicines, including aspirin, may be as effective as opioids.

Pills – illustrative photo. Image credit: Pixabay (Free Pixabay license)

Researchers examining the data on opioids for pain caused by cancer have found surprisingly large gaps in evidence regarding the true benefits of these medicines for cancer pain. The study challenges the commonly held view that opioids are the most powerful pain relievers.

The study, led by The University of Sydney and including The University of Warwick highlights that there is no ‘one size fits all’ treatment approach for cancer pain, urging health professionals and patients to carefully weigh up the evidence when deciding on a suitable pain management plan.

Opioid pain relievers are the most common treatment for cancer pain management. Many international guidelines including the World Health Organization, recommend opioid medications to manage background cancer pain (constant pain) and breakthrough cancer pain (temporary flare-ups of pain in addition to background pain).

However, the study found very few trials have compared commonly used opioid medicines such as morphine, oxycodone and methadone with placebo.

The study did not find convincing evidence that morphine was better or safer than other opioid medicines for background cancer pain outside of end-of-life care.

This is despite morphine being widely viewed as the ‘gold standard treatment’ for cancer care by physicians and recommended in many international clinical guidelines for moderate to severe cancer pain because of its low cost and accessibility.

The review also found non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin and diclofenac may be as effective as some opioids for background cancer pain.

“People with background cancer pain may have an overall better life experience if there is less focus on using opioids to reduce their pain level,” says co-author Professor Martin Underwood from the University of Warwick.

“The lack of evidence comparing opioid medicines to placebo for cancer pain probably reflects the ethical and logistical challenges associated with carrying out such trials. Yet these trials are necessary to guide clinical decision making,” says lead researcher Dr Christina Abdel Shaheed from the University of Sydney School of Public Health, Faculty of Medicine and Health and Sydney Musculoskeletal Health which is an initiative of the University of Sydney, Sydney Local Health District and Northern Sydney Local Health District.

“In practice, opioids are indispensable for intractable pain and distress at the end of life. What is worth highlighting is that non-opioids, particularly NSAIDs, are surprisingly effective for some cancer pain, and may avoid the problems of dependence and waning opioid analgesia over time,” says co-author Professor Jane Ballantyne, from the University of Washington School of Medicine, USA.

“The hope is that the findings can help guide doctors and patients to choose between different opioid treatment for cancer pain and empower individuals to consider alternatives if they are unable to tolerate opioid medicines or choose not to take them,” said senior author Dr Mark Sidhom, from the Cancer Therapy Centre, Liverpool Hospital, Australia.

The results are published in CA: A Cancer Journal for Clinicians today.

DOI: https://doi.org/10.3322/caac.21823

Source: University of Warwick

You can offer your link to a page which is relevant to the topic of this post.

#Accessibility #approach #Australia #background #Cancer #cancer pain #Cancer Therapy #data #decision making #drugs #Faculty #Featured life sciences news #gold #guidelines #Health #Health & medicine news #it #LED #LESS #life #Link #management #medications #Medicine #One #opioids #organization #Other #pain #photo

[sanemyamen]

Bio-pharmaceuticals Market Look a Witness of Excellent Long-Term Growth – Worldwide Survey by 2028

The Latest Released market study on Global Bio-pharmaceuticals market provides information and useful stats on market structure, size and trends. The report is intended to provide cutting-edge market intelligence and strategic insights to help decision makers take sound investment decisions and identify potential gaps and growth opportunities. Besides, the report also identifies and analyses changing dynamics, emerging trends along with essential drivers, challenges, opportunities and restraints in Bio-pharmaceuticals market. What’s keeping Pfizer (United States),F. Hoffmann-La Roche AG (Switzerland),AbbVie(United States),Johnson& Johnson (United States),Sanofi (France),AstraZeneca (United Kingdom),Novartis (Switzerland),Novo Nordisk (Denmark),Merck & Co., Inc. (United States),Eli Lilly and Company (United States),Bristol-Myers Squibb Company (United States),Cadila Healthcare Limited (Zydus Cadila) (India),Amgen (United States),Abbott Laboratories (United States),Biocon Ltd (India) Keep Growing in the Market? Benchmark yourself with the strategic moves and latest Market Share and Sizing of Global Bio-pharmaceuticals market recently published by AMA Basically,  Bio-pharmaceuticals are categorized under the pharmaceutical industry. The combination of biological applications with pharmaceutical enhancements the new department of Bio-Pharma introduced. Bio-pharmaceuticals drugs and therapies are therapeutic agents initialized to treat symptoms and/or underlying causes of a variety of disorders and diseases. Commonly, it is also known as bio-pharmaceutical. It opens doors for various medications for untreated diseases and disorders with very few side effects. The Bio-pharmaceuticals Market segments and Market Data Break Down by Type (Monoclonal Antibodies (moAb), Biotech Vaccines, Recombinant Human (RH) Insulin, Erythropoietin, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Human Growth Hormones (HGH), Other Biopharmaceuticals), Application (Oncology, Autoimmune Disorders, Diabetes, Inflammatory and Infectious Diseases, Neurological Diseases, Cardiovascular Diseases, Others), End Users (Pharmaceutical companies, Biopharmaceutical companies, Hospitals and clinics, Research and development centers, Clinical trial centers), Technology (Genome-based technologies, Gene therapy, Software, Artificial Intelligence), Sales Channel (Prescription, OTC)

On the geographical front, the market has been segregated into North America (the United States and Canada), Europe (Germany, France, the United Kingdom, Italy, Spain, Russia and others), Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia and others), Latin America (Brazil, Mexico and others), and Middle East and Africa.

What’s Trending in Market: Highly Demanded as Alternative For Many Traditional Medications

Market Challenges: Research Studies Take A Long Time Period Getting Desirable Results

Stringent Regulatory Guidelines

Market Opportunities: Occurrence E Of Chronic Diseases Like Cancer, HIV/AIDS And Diabetes, Etc

Growing Acceptance And Adoption  Of Biopharmaceuticals Due Effectiveness In Untreatable Diseases

Highlights of Influencing Drivers: Growing Elderly Population

Biopharmaceuticals Provide Several Advantages As They Are Highly Effective And Potent In Action With Only A Few Side Effects

Presented By

AMA Research & Media LLP

[researchnesterreports]

Central Lab Market to Grow by a CAGR of ~6% During 2022 – 2031; Market to Grow on Account of Increasing Advancement of Novel Drugs and Devices to Treat Genetic Disorders

Research Nester published a report titled “Central Lab Market: Global Demand Analysis & Opportunity Outlook 2031” which delivers detailed overview of the global central lab market in terms of market segmentation by service type, end-user, and by region.

Further, for the in-depth analysis, the report encompasses the industry growth indicators, restraints, supply and demand risk, along with detailed discussion on current and future market trends that are associated with the growth of the market.

The global central lab market is estimated to grow with a CAGR of ~6% over the forecast period, i.e., 2022 - 2031. The market is segmented by end-user into biotechnology companies, pharmaceutical companies, and research institutes. Amongst these, pharmaceutical companies segment projected to grow at the highest rate during the forecast period backed by the rising occurrences of several genetic disorders, and the continuous clinical trials for new drugs formulation.

Download Sample PDF: https://www.researchnester.com/sample-request-4233

The global central lab market is estimated to garner a revenue of ~USD 4 Billion by the end of 2031 by growing at a CAGR of ~6% over the forecast period, i.e., 2022 – 2031. Further, the market generated a revenue of ~USD 2 Billion in the year 2021.

The global central lab market is projected to significantly expand owing to the growing occurrences of several genetic illnesses, followed by the increasing number of genetic testing to detect the suspected genetic condition. Besides this, rise in cancer cases and increasing investment in research and development are some of the major factors anticipated to drive the growth of the market in the forecast period.

Geographically, the global central lab market is segmented into five major regions comprising of North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The market in the North America region is estimated to witness significant growth over the forecast period on the back of increasing awareness in patients regarding the importance of clinical tests, escalating occurrences of chronic and infectious illnesses, and a noteworthy ratio of research and development in the region.

The research is global in nature and covers detailed analysis on the market in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC [Finland, Sweden, Norway, Denmark], Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Singapore, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa). In addition, analysis comprising market size, Y-O-Y growth & opportunity analysis, market players’ competitive study, investment opportunities, demand for future outlook etc. has also been covered and displayed in the research report.

Worldwide Increasing Surge in Numerous Genetic Disorders to Drive the Market Growth

Over 6,010 clinically defined rare diseases exist, and 72% of these disorders are genetic.

Typically, a genetic disorder occurs by one or more deformities in the genome. Such disorders include a wide range of chronic diseases and birth defects hereditary from one or both parents. Genetic disorders are a major cause of impairment, death, and desolation in humans. Thousands of distinct genetic disorders with characterized clinical symptoms have been identified up to now, still we need more exploration to understand and to formulate a significant treatment to get relieve from such syndromes. Therefore, numerous clinical studies and trials have been running throughout the world to set a benchmark in the clinical research and this factor is fueling up the growth of global central lab market.

However, rigorous government guidelines, contamination issue of samples, and prerequisite of extreme investments are expected to operate as key restraint to the growth of the global central lab market over the forecast period.

This report also provides the existing competitive scenario of some of the key players of the global central lab market which includes company profiling of Clinical Reference Laboratory, Inc., Lambda Therapeutic Research Limited, Laboratory Corporation of America Holdings, Medpace, Inc., InVitro International (IVRO), LabConnect, Eurofins Scientific (Ireland) Limited, Cerba Research NV, and others. The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials and recent news and developments. On the whole, the report depicts detailed overview of the global central lab market that will help industry consultants, equipment manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market centric strategies according to the ongoing and expected trends in the future.   

Do You Have Any Query Or Specific Requirement? Ask to Our Expert: https://www.researchnester.com/ask-the-analyst/rep-id-4233 

About Research Nester

Research Nester is a leading service provider for strategic market research and consulting. We aim to provide unbiased, unparalleled market insights and industry analysis to help industries, conglomerates and executives to take wise decisions for their future marketing strategy, expansion and investment etc. We believe every business can expand to its new horizon, provided a right guidance at a right time is available through strategic minds. Our out of box thinking helps our clients to take wise decision in order to avoid future uncertainties.

Contact for more Info:

AJ Daniel

Email: [email protected]

U.S. Phone: [phone]

U.K. Phone: [phone]

#Central Lab Market

[rmceducation]

Study MBBS in Kyrgyzstan

Studying MBBS in Kyrgyzstan has now become a great alternative for Indian students. It is associated with various clinical trials, experienced resources, medical clinics and unique food quality. MBBS in Kyrgyzstan is a five to six-year course depending on the university and 100% English medium throughout the course. Medical education in Kyrgyzstan is excellent; It meets the guidelines of universal instruction.

In previous years, there has been a huge trend of students studying MBBS abroad. MBBS in Kyrgyzstan is one of the commendable choices for Indian students to pursue medicine abroad. Studying in medical colleges of Kyrgyzstan provides excellent skills in training, regional pathology training, diagnostic learning, patient care, clinical care and much more.

Kyrgyzstan, one of the leading countries offering MBBS to Indian students, has seen its number of Indian students for medical studies increase at a rate of 21.54% per annum over the last half-decade. Studying MBBS in Kyrgyzstan is very practical as you analyze medical courses in India as well as in different countries like USA, U.K., Australia, China and Russia. The amount you pay per year for MBBS in India is nothing like what you pay for 6 years of MBBS in Kyrgyzstan.

The cost of education and various expenses such as travel expenses, accommodation rents and food expenses are relatively less in Kyrgyzstan than in other countries. What's more, Kyrgyzstan universities accept direct admission and students don't need to clear any entrance exam to study MBBS in Kyrgyzstan. Kyrgyzstan Medical University requires Indian students to have 50% marks in Physics, Chemistry and Biology in their final year of schooling. Every medical school in the country teaches in English medium, and different dialects such as Russian or Kyrgyz are not used in classes and assessments.

#Study MBBS in Kyrgyzstan

[mistonki]

Sentinel node

SENTINEL NODE SKIN

SENTINEL NODE TRIAL

The STROBE guidelines were followed to report the findings. Analyses were conducted using SAS version 9.4. Factors assessed were age, sex, type of practice, years of practice, number of invasive melanomas diagnosed in a year, ARIA, SEIFA and exposure to articles or talks about SLNB. Univariable and multivariable prevalence ratios and 95% confidence intervals (CIs) were calculated using Poisson regression models to examine factors associated with familiarity with Australian melanoma clinical practice guidelines and knowledge about and attitudes towards SLNB. Postcodes were classified using the Accessibility Remoteness Index of Australia (ARIA) 13 and Socio-Economic Indexes for Areas (SEIFA) 14 classifications. The questionnaire data were managed using REDCap. The questionnaire was completed on paper or electronically and consisted of 24 items covering demographic characteristics, knowledge of melanoma guidelines, clinical management of melanoma, referral patterns, and attitudes to SLNB and shared care. Questionnaire and interview guide developmentĪ cross-sectional questionnaire and semi-structured interview guide (Supplementary file available online only) were developed from a literature review and discussion with a multidisciplinary team of melanoma clinicians and researchers. Of these, 23 also completed an interview and were reimbursed $100 for their time. Overall, 231 GPs completed a questionnaire. GPs were eligible to participate in the study if they had practised in Australia in the previous year.

SENTINEL NODE SKIN

Recruitment of GPs was conducted at two Australian GP meetings: the Royal Australian College of General Practitioners (RACGP) annual conference in Queensland in October 2018, and a GP skin cancer–focused continuing medical education workshop in Sydney in December 2018 participants were also recruited through other GP professional communications. Quantitative and qualitative data were collected in the form of questionnaires and interviews. The aim of this study was to examine the knowledge and attitudes of GPs regarding the role of SLNB in the management of patients with invasive primary melanomas, to assist development of and adherence to guidelines. 10,11 Potential reasons for low uptake of SLNB include confusion about the evidence, lack of awareness of the guidelines, and individual preferences of GPs and patients. 7 There have been conflicting interpretations of the results from MSLT-I and other studies examining the benefits of SLNB in relation to the therapeutic value 8,9 and survival benefit of SLNB.

SENTINEL NODE TRIAL

6 The Multicenter Selective Lymphadenectomy Trial (MSLT-I) showed improved disease-free survival but not overall melanoma-specific survival following SLNB. Data from the NSW Melanoma Patterns of Care study indicated that SLNB was undertaken for 45% of patients diagnosed with a melanoma >0.8 mm Breslow thickness who were potentially eligible for SLNB. 5 Historically, adherence to SLNB guidelines has not been optimal, allowing for patients who may refuse or not be suitable for SLNB. 5 SLNB should be performed at the time of the primary tumour wide excision. 1 The NSW Melanoma Patterns of Care study, 2 a population-based survey of in situ and invasive melanoma management in NSW in 2006–07, found the initial melanoma diagnosis was managed in general practice for 36% of patients, in skin cancer clinics (usually staffed by GPs) for 17%, in dermatology practices for 26%, by surgeons for 13% and by others for 1 mm in thickness and for patients with melanoma >0.8 mm in thickness with other high-risk pathological features. Some GPs with a special interest in skin cancer also perform wide excisions and flap repairs. A GP is therefore the person who will most often make a preliminary diagnosis, take the first biopsy and, following pathological confirmation of melanoma, decide on the need for referral for specialist care. In Australia, general practitioners (GPs) are the first point of contact for the majority of patients who develop melanoma.

#Sentinel node

[mitconconsultancy123]

Advanced PG Diploma in Clinical Research, Clinical Data Management and Pharmacovigilance

MITCON’s Technology BUSINESS INCUBATOR Provides Training facility for various disciplines in Bio-Technology, agriculture, food processing and Pharmaceutical to boost commercialization through incubation.

Module 1

Introduction to CR

Drug development, IND

History of clinical research

Clinical research industry and opportunities in India

Module 2

Regulatory aspects of CR

ICH GCP

Schedule Y

Belmont report, Declaration of Helsinki

Module 3

Monitoring of Clinical Trails

Auditing

Pharmacovigilance

Module 4

Bioavailability bioequivalence studies

Overview of clinical data management

Overview of biostatics

Medical writing

Module 5

Clinical Trial Design

Protocol

Informed Consent

IRB/EC

Module 6

Regulatory Affairs Profession in India

ICH Quality Guidelines

Regulatory system for Europe, US, Australia, New Zealand, Semi Regulated Markets

Introduction to Intellectual Property & Guidelines.

For More Information,

Contact-  02066289452

Visit: https://www.mitconbiopharma.com/training/advance-pg-diploma-in-clinical-research/

[itakecareofsickpeople]

Why Do I Hate Ivermectin?

I was asked to do an article on ivermectin and I feel that it is important to understand the science behind ivermectin (and HCQ).  I think if you know the science, you will be as skeptical as I am.

I was once being quizzed by an Attending Physician when I was a resident.  I stuttered as I was answering and said, “I think…”  He stopped me mid-sentence and said, “Son, you are a second year internal medicine resident, I don’t give a shit what you think.  What do you know?”

You see, it really isn’t relevant to all of you what I think. You aren’t interested in my opinion.   You are reading this post because you are interested in what I know.  I don’t take anything at face value and I always read all of the studies that people are using as a reference to prove a point. The thing is, most “studies” aren’t worth the paper they are printed on and don’t actually “study” anything.  Worst thing is, sometimes it’s a fake.  

We all know about the faked anti-vaccine trial by Andrew Wakefield, the completely discredited, former doctor, who started the anti-vaccine movement by faking data on autism and vaccines. In case you didn’t, he faked the original anti-vaccine study and In 2010, the British General medical council found that Wakefield “had been dishonest in his research, had acted against his patients' best interests and mistreated developmentally delayed children.”  That’s right anti-vaxxers. That’s your start, one giant lie. 

I have read all of the studies that I will make reference to in this post and regrettably, every study I can find on ivermectin. As of now, I do not see any evidence that supports the use of ivermectin for Covid in humans outside of a clinical trial. Hey! That’s what the cdc says too….odd. 

In general, American doctors are snobby.  We want studies from Europe, Israel, Australia, Canada and the good ole USA.  We don’t want studies from countries with dictatorships or totalitarian regimes.  These countries have a long track record of producing fake studies and bad studies.  Countries such as China, Egypt, Iran, Iraq, Brazil, Venezuela, etc.  You know, the same governments that hack us and steel info from us, those ones.  It is in their governments interest to make all of their people think they have a treatment for covid, otherwise there would be revolts.  American doctors generally would never consider a study from Egypt as high quality, unless it was published in a very well respected journal.  There just isn’t any quality control.

The science behind HCQ is basically the same, except with ivermectin, a large clinical trial showing it helped, was all fake.  HCQ just didn’t work.  Lots of us used HCQ at the beginning of covid until real studies were done showing it didn’t work and may actually worsen outcomes.

Remember, most drugs are safe in normal doses, but toxic in doses outside of the “therapeutic window” that is the dose that both will have the desired effect, but also is safe and well tolerated.  Too little drug, it doesn’t work, too much drug, it causes toxicity. 

First, It is very important to test all drugs that are easily available for activity in covid.  This starts in a test tube. Ivermectin was approved in 1996 for the treatment of  strongyloides and hookworms.  In animal studies, it is lethal in overdose and causes toxicity at 10x the approved dose.  It also was found to be a teratogen (birth defects) and is not approved for use in pregnant women.  Otherwise, it is quite safe and effective in comparison to approved treatments of the time and was approved after being studied in about 1700 patients (half given ivermectin, half given old treatments).  It is widely available and is pretty safe (Except in pregnancy).

Ivermectin was found to have in vitro (test tube) activity against the SARS COV2 virus.  I know that sounds great, but remember what we said about the therapeutic window. It was shown, in the test tube, to inhibit activity of covid by 50% at a concentration of 2 μM (1,750 ng/mL), which is > 35× higher than the maximum plasma concentration (Cmax) of 0.05 µM (46.6 ng/mL) after oral administration of the approved dose (~ 200 μg/kg) and ivermectin showed little to no activity at 1 μM in vitro. 

Wait, so that means you would need 35 times the approved dose to inhibit covid and ivermectin is toxic at 10x the dose.  It also causes birth defects?  Count me out.

As you might imagine, based on this knowledge it is very hard for me to believe that you can safely dosed ivermectin could have any benefit for covid.  Now, on to the bad studies. 

Remember what I said about studies from certain countries?  

In November, an article from Egypt was published without review in an online site called Research Square.  Never heard of it? Me either?  It showed a 99% reduction in mortality.  Holy crap, that’s amazing, right?  Of course.  Despite it having such a completely unrealistic outcome, many doctors picked this up and ran with it.  In America, a group of doctors that named themselves the FLCCC, led by two guys named Paul Marik and Pierre Kory, latched on to this and started spouting its effects. I personally have a lot knowledge and not a lot of respect for Marik’s work predating covid. His FLCCC “treatment guidelines” have never been evidence based and in general he has never been able to publish studies that prove his claims.

So after this first study from Egypt comes out, a bunch of studies follow and are picked up by Marik’s group.  They did a “review” of them and included the Egyptian study. Most of the studies aren’t even reviewed and are published online as “preprint.” They are from Egypt, India, Iraq, Bangladesh, Pakistan, Peru, Nigeria, Mexico, and Argentina.  None of these places are exactly known for being in the 1st world and none of the other studies showed the massive effect as the Egyptian study.  

Then, a medical student in the UK is assigned the Egyptian study for a report. He actually reads the study.  It doesn’t make sense.  He then requests more information from the authors and they sent him the “patient data.”  It was clearly faked and he got some journalists involved.  After they involved an expert on faked studies, the study was then taken down from Research Square over “ethical concerns.”  Too bad Marik didn’t bother to do what the med student did.

Unfortunately, this has led to a massive amount of confusion.  If you think that there is a treatment for covid, you might not take the vaccine.  Even If it worked, we would be taking about a minimal effect.   Heck, it could even be toxic if you give it to that many people.  The other big problem is we have to do a bunch of American studies to see if it does work.  Studies that could have been done with another treatment.  What a waste of time and lives. 

So why do I hate ivermectin?  Well, I don’t.  I hate the waste of time I have spent writing this article to discuss a drug that could only be effective for covid if you took enough to kill you.  I hate the people that faked the study, they have cost lives.  I don’t hate Marik, but I definitely think he is crazy and I’m not interested in what he thinks and that isn’t new.  Unfortunately he has a big microphone and I just have this little one.

My biggest recommendation is ask your doctor if you should have the vaccine.  If you trust YOUR doctor, listen to HIM or HER.  Not some YAHOO online like ME. Remember, you trust your doctors to take care of your babies, born and unborn, cut you open, give us anesthesia and put cameras in all our holes. You trust them to help you make major medical decisions about your life. Keep doing that, they care about you. We care about you. 

Please, don’t post any articles in support of ivermectin. I read them and found them lacking. Also, don’t post another doctors opinion of ivermectin. I don’t care what they think, just what they know.

PS: I am a Critical Care Pulmonologist, I take care of sick people. Hopefully that won’t be you.

Oh yeah. Feel free to share. I should really charge for these.

#itakecareofsickpeople #covidsucks #covid

[ucsdhealthsciences]

What Will it Take to Create a Vaccine for COVID19?

April 29, 2020, 3:30 p.m. — One of the big challenges in navigating the COVID-19 crisis is the novelty of the virus. Because it’s so new, we don’t have any way to prevent infection — and without a vaccine, there’s no telling how long the pandemic will last. So what will it take to get a COVID-19 vaccine available to the public? And why is it taking so long?

What we know about COVID-19

Viruses operate by attaching themselves to living cells in our body and injecting their genetic material, called RNA. The RNA hijacks the machinery of the cell to replicate itself, producing copy after copy of the virus, which eventually explode out of the cell to go in search of new cells to infect. In the case of SARS-CoV-2, the virus primarily attacks the epithelial cells lining the lungs. In the lungs, the fight between your immune system and the virus can cause inflammation, cell death and excess fluid, a combo that leads to pneumonia. Sometimes, when the infection is really bad, patients end up with acute respiratory distress syndrome, or ARDS, when their lungs are so clogged up that their bodies aren’t able to absorb enough oxygen and they really struggle to breathe.

There’s also evidence that the virus, and/or the inflammation it causes, might be having effects on other organs in the body, causing long term complications including brain, liver, kidney, and heart damage and increased risk of blood clots.

Protection against a viral illness is conferred by antibodies, produced by the immune system in response to exposure to the virus. In most cases, contracting the virus gives the immune system the information it needs to produce those antibodies, which can then activate and fight the virus on the next exposure.

What it takes to develop a vaccine

Vaccines take advantage of our natural immune system response to stimulate antibody production against a disease using killed or weakened versions of the pathogen that don’t make us sick. This makes us immune to the disease without ever having to contract it.  

The first step in creating a vaccine is to identify a good antigen to target. These molecules represent portions of the virus’ structure that don’t cause illness by themselves but do activate the immune system to produce the correct antibodies. These antigens are then produced in large quantities by cells in Petri dishes before being purified and, if necessary, the virus is inactivated or killed so it can be safely injected. Finally, the antigen is mixed with adjuvants, to help enhance the immune response to produce stronger immunity, alongside preservatives and stabilizers to give the vaccine a long shelf life and allow for multiple doses from the same vial.

Once a vaccine has been created, it has to be extensively tested: first in animal models, and eventually in human beings. This process goes through three phases, to be sure that the vaccine is safe and effective, and to determine what dose should be administered to patients. It takes a lot of testing to be sure that the vaccine is safe in children, adults, pregnant people, and the elderly. And not every vaccine is recommended for every person. Different governments have to balance cost, risk, efficacy, and public health concerns before deciding whether or not they should add a new vaccine to the standard vaccination list.

Usually, it takes 10 to 15 years to develop a vaccine and get it approved by the FDA for use in patients. The exception are seasonal vaccines, like the flu vaccine. Because the flu virus is tracked year-round by scientists, and because the manufacturing process is kept the same year-to-year, researchers are able to use the same foundation for each year’s vaccine and simply replace the antigen with the new virus.

In the case of SARS-CoV-2, because of the high rates of infection and novelty of the virus, it seems critical that we get a vaccine ready quickly, but it’s not as easy just swapping in a new antigen. Thanks to a lot of technological advancement in recent years, and the large number of industrial and academic researchers working on this problem, we’re moving faster than ever toward a vaccine solution for COVID-19.

What’s already happening on the vaccine front?

The SARS-CoV-2 genetic sequence was published on January 11, 2020, allowing for a global flurry of vaccine development, and the first vaccine entered human clinical trials on March 16. By April 8, 115 vaccines candidates were being tested by academic research institutions and industry companies, with 78 of those candidates being close to formal testing. Several of those have already advanced into clinical testing, with several others hoping to follow within the next several months.

The rapid speed of vaccine development is thanks to a wide diversity of technology platforms, testing a variety of potential sources for stimulating the immune response, including peptides, viral vectors, recombinant proteins, and nucleic acids (DNA and RNA). Researchers are also working to develop adjuvants that will produce the most effective vaccines. Most of these vaccines are being tested in the United States and in China, with some development in Europe, Australia, and other areas in Asia.

What we still need to know and do

We still need to figure out some key details about the SARS-CoV-2 virus. One big question that we haven’t answered yet is whether or not exposure to the virus, or to viral antigens, is enough to generate immunity to the virus. The evidence so far suggests that people who have contracted COVID-19 are protected against reinfection, at least temporarily.

Some cases have indicated that patients who experience a more severe infection of the virus may have more antibodies against it, which may provide better protection against future illness. But it’s still unclear if contracting the virus provides any lasting immunity against it, or how long that immunity might last. At this point, virologists believe that immunity is limited; after 1 to 2 years, patients may be susceptible to a new infection, and require a vaccine to protect against it.

Another question is whether or not COVID-19 is at risk of mutating to become more deadly. At this stage, we just don’t know enough about the virus and its behavior to be certain one way or the other, though some experts doubt that there is a high risk of this happening.

Until some of these vaccines have gone through further clinical testing, we won’t know which ones are actually viable candidates for the public. Part of the challenge is the fact that most vaccines require years of testing in the community, where trial participants receive the vaccine or receive a placebo and then go about their daily lives to see if they end up contracting the virus. Because of the drastic impacts of COVID-19 on our lives and economy, some scientists are suggesting that we consider clinical trials where healthy volunteers are given the vaccine and deliberately exposed to SARS-CoV-2 to see how effective the vaccine might be. This could shave months off the development timeline, but is highly controversial due to the obvious risks for trial participants.

So when will we have a vaccine?

With all of these projects underway, scientists think a vaccine may be approved for emergency use by the FDA as soon as 2021. “Emergency use” means that a vaccine has been tested in humans and found to be effective at preventing infection, but hasn’t been subjected to the full, rigorous scrutiny of a traditional vaccine. It will take more time for all of this extensive testing to be completed — likely several more years.

Despite recent technological advances, this means it will still be at least a year before we have a viable vaccine. With that in mind, the CDC and other public health officials continue to recommend that we follow physical distancing, hand washing and mask-wearing guidelines. It’s important that we continue to work together to protect the health of our friends, family, and community by following stay-at-home recommendations as doctors and scientists work not only on developing a vaccine, but also at better understanding how the virus works and figuring out the most effective ways to treat it.

For more information on what we’re doing at UC San Diego Health, please visit health.ucsd.edu/COVID

— Alison Caldwell, PhD, Bigelow Science Communication Fellow

#covid-19 #covid 19 #novel coronavirus #coronavirus #sars-cov-2 #vaccine #immunology #infectious disease #public health #clinical trials #vaccine protocol #vaccine production #stay at home #flatten the curve #pandemic #hand washing #hand hygiene #shelter in place #self quarantine #quarantine #social distancing #science #medicine #academic medicine #ucsd #uc san diego

[radishreader]

There have been some attempts to force researchers to properly represent females in medical research. Since 1993, when the US passed the National Institute of Health Revitalization Act, it has been illegal not to include women in federally funded clinical trials. Australia’s main funding body made similar rules for the research it funds, as has the EU, which in fact went even further, also requiring both sexes to be studied in pre-clinical animal studies. This requirement did not come into effect in the US until January 2016, which is also when the NIH introduced the requirement that the data in trials it funded be disaggregated and analysed by sex (unless there is a compelling reason not to).

Other positive developments include the German Society of Epidemiology which has for more than a decade required researchers to justify including only one sex in any study where the results could potentially affect both sexes; and the introduction of the same by the Canadian Institutes of Health in 2012, as well as mandatory questions about the consideration of sex and gender in the study design. Some academic journals also now insist that papers submitted for publication should provide information about the gender of participants in clinical trials, for example.

Trailing behind everyone is the UK, whose main funders ‘make no substantive reference to, or requirements regarding, the consideration of gender in research design and analysis’, and despite the at-risk population of women suffering more morbidity and mortality, UK research funding for coronary artery disease in men is far greater than for women. Indeed, such is the dearth of gender-based clinical research from within the UK, that Anita Holdcroft, emeritus professor at Imperial College London, has written that for cardiovascular treatment, ‘it is pertinent to use studies from North America and Europe where these issues have been investigated’.

Still, while the situation in the UK is dire, significant problems remain elsewhere. For a start, the evidence we’ve just seen on the representation of women in trials suggests that these policies are not being rigorously enforced. And, indeed, this is what analyses of the NIH have found. Four years after the NIH announced their first policy calling for the inclusion of women in medical trials, a report was released by the GAO which criticised the NIH for having ‘no readily accessible source of data on the demographics of NIH study populations’, making it impossible to determine if the NIH was enforcing its own recommendations. By 2015 the GAO was still reporting that the NIH ‘does a poor job of enforcing rules requiring that clinical trials include both sexes’.

There also remain plenty of loopholes for US drug manufacturers who don’t want the cost and complication of including unharmonious females with their messy hormones in their neat clinical trials, because the rules only apply to NIH-funded trials; independent drug manufacturers can do whatever they want. And the evidence suggests that many of them do: a 2016 paper found that ‘a quarter of the drug manufacturers in an industry survey did not deliberately recruit representative numbers of women as participants in drug trials.’ When it comes to generic drugs, the FDA only specifies ‘guidelines’ rather than rules and, as we’ve seen, these guidelines are being roundly ignored. And the NIH policy on including female subjects in clinical trials doesn’t apply to cell studies.

--Caroline Criado-Perez, Invisible Women (2019)

#caroline criado perez #invisible women

[lovingconnoisseurbanana]

Statistical Considerations of Pre-Clinical Research Studies

Surely, even before a medicine could be attempted in a clinical fundamental, the improvement collaboration of a drug all around incorporates three critical advances, including divulgence, preclinical unforeseen development, and a while later clinical starter. The advancement from exposure to preclinical improvement is a persistent association. The results got from toxicology and preliminary pharmacology testing regularly add to contender decision for a prescription. The recording of an Investigational New Drug (IND) sets up a breaking point between preclinical new development and clinical research of a medicine. The clinical trials and preclinical studies is precisely performed by the associates that are given the best clinical research training.

  The going with overall affiliations ensure drug security and sufficiency:

 ●         World Health Organization (WHO),

 ●         Pharmaceutical Inspection Co-movement Scheme (PIC/S),

 ●         International Organization for Standardization (ISO),

 ●         International Conference on Harmonization (ICH),

 ●         Parenteral Drug Association (PDA), and

 ●         International Society for Pharmaceutical Engineering (ISPE).

 A segment of the public authoritative bodies giving guidelines for drug headway include:

 ●         European Medicines Evaluation Agency (EMEA), Europe

 ●         Food and Drug Administration (FDA), US

 ●         Regulatory Operations and Enforcement Branch of Health Canada (ROEB), Canada

 ●         Pharmaceuticals and Medical Devices Agency (PMDA), Japan

 ●         Medicines and Healthcare things Regulatory Agency (MHRA), UK

 ●         Brazilian Health Regulatory Agency (ANVISA), Brazil

 ●         Therapeutic Goods Administration (TGA), Australia

 ●         Turkish Medicines and Medical Devices Agency (TMMDA), Turkey

 Should clinical primers be driven locally?

 A commonplace request that much of the time inspires an emotional response is whether clinical fundamentals are should have been coordinated locally as a communicated or certain condition to get advancing support. The greater part of countries, including India, require clinical fundamentals to be driven locally as a pre-condition for getting advancing support. It is done to show the prosperity and suitability of a prescription or clinical device that satisfies the significance of another drug and investigational clinical contraption, separately.

 How are clinical fundamentals financed?

 Notwithstanding where the allies are combined, clinical fundamental supporters can directly back a clinical primer. The patrons are at risk for picking a gathering of inspectors and a real expert who by then drives the gathering of specialists. The ally of a clinical starter can directly pay the inspectors for their organizations. The help is in like manner permitted to make portions for the site, also picked by the help, for the clinical fundamental for giving in-patient workplaces, among various others. In the event that there ought to emerge an event of experts being the site labourers, the help can make direct portions to the site, which is accordingly redistributed to the specialists.

 Essentials for preclinical and clinical primer norms

 Clinical starters seek after only support of an once-over of preclinical primer guidelines and shows. Various public and overall laws administer these principles and shows. In India, The Prevention of Cruelty to Animals Act, 1960 (PCA Act) and The Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998 (BEACS Rules) laid out under the PCA Act deal with the preclinical fundamentals or studies on animals. The BEACS Rules communicates that any show for preclinical primers should ensure that animals at first considered for any test framework should stand generally decreased on the phylogenetic scale, which may give tentatively generous results. The examination should be proposed so much that a base number of animals are used to give quantifiably genuine results, setting up a 95 percent level of assurance.

 Before preliminaries can be coordinated on animals, investigate express assent is required from an appointed warning gathering or authority. As coordinated by different laws overseeing preclinical fundamentals and clinical research courses across the world, a bit of the fundamental essentials consolidate assessment thinking, study setup, subject capability, study treatment, and establishment of the chief specialist. Generally, an ethics leading body of trustees is similarly set up to review and support the clinical fundamental going before its exercises inception. The ethics leading group of trustees is furthermore obligated for surveying and avowing any movements or updates made to the clinical primer shows going before their execution. In any case, prior underwriting from the ethics warning gathering isn't required when the execution of updates is fundamental for patients' prosperity and security.

 Preclinical assessment

 Before a medicine or treatment can be taken a stab at people, clinical experts should ensure whether it can cause anticipated perils, results, or certified harms, in any case called harmfulness to the patients. The two kinds of preclinical investigation join the going with:

 ●         In Vitro

 ●         In Vivo

 In the US, the FDA indicates that researchers ought to use incredible exploration office practices (GLP), as described in clinical thing improvement rules for preclinical lab mulls over. The GLP rules set the base major requirements for:

 ●         study lead

 ●         personnel

 ●         facilities

 ●         equipment

 ●         written shows

 ●         operating techniques

 ●         study reports

 It furthermore develops a course of action of significant worth insistence for each preclinical assessment to ensure the prosperity and suitability of things supported and coordinated by the FDA. Generally, preclinical examinations are not coordinated on a particularly gigantic extension. Regardless, these assessments should give distinct information on dosing and destructiveness levels. Clinical examiners review their results after preclinical testing.  

Preclinical examinations encompass various activities that fill in as an association between drug disclosure and status and the initiation of a clinical primer on individuals. The laws coordinating preclinical starter principles and necessities worldwide can package differentiates anyway generally have some essential features. Rodent and non-rodent mammalian models are overall used to introduce general prosperity and recognize destructiveness plans that uncover potential target organs inclined to persevere through the unpleasant effects. Toxicology and security focuses also perceive Therapeutic Index for picking the fundamental starting measurements in clinical primers. Past what in any event one creature gatherings can be used for choosing the drug's mean home time in the body. The mean home period of a medicine in the body depends upon natural ingestion, dispersal, processing, and release properties.

#clinical research courses #clinical research training

[25000yearcycle]

Unmasking the Surgical Mask

Unmasking the Surgical Mask: Does It Really Work?   

by  Crystal  Phend,                    Senior Staff Writer, MedPage Today             October 5, 2009         

For a century, the surgical mask has been the symbol of a safe and sanitary medical environment. The problem: researchers don't really know if that's true.

With the H1N1 influenza pandemic spreading every day, experts are still debating what type of mask to wear and how much protection that mask truly provides, particularly for those at the front lines of transmission  --  healthcare workers.

Major health agencies, including the World Health Organization, the CDC, and others, have offered confusing and sometimes contradictory guidelines.

Moreover, those guidelines differ for healthcare workers and ordinary citizens worried about the spread of H1N1. Even among healthcare professionals, there are different guidelines for medical wards and operating rooms.

Still, most healthcare professionals have concluded that, at the very worst, a mask can't hurt, even if it may provide a false sense of safety.

The notion of covering the nose and mouth for infection control actually dates back more than a century to the period when German physician Carl Flügge discovered that exhaled droplets could transmit tuberculosis.

The modern surgical mask, successor to the crude gauze strips those early doctors and nurses employed, is still primarily designed to prevent the passage of relatively large particles, such as sputum droplets and hair.

A high tech version  --  the so-called N95 respirator  --  seals tightly around mouth and nose and is made of material certified to block 95% of particles 0.3 μm or larger in diameter, roughly the size of a single virus. There's something resembling agreement that, worn properly, these do their job.

Conflicting Guidelines

CDC recommends surgical masks as part of the overall arsenal deployed against seasonal flu, but along with the Institute of Medicine, CDC has recommended only N95 respirators for protection against H1N1  --  in part, because animal studies suggest airborne transmission of the virus via small particles.

Not so for the World Health Organization or the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of America, the Association for Professionals in Infection Control and Epidemiology, and the American College of Occupational and Environmental Medicine.

They collectively recommended regular surgical masks except in high risk circumstances, such as during open suctioning of airway secretions and other procedures that could "aerosolize" the H1N1 virus.

There's a good reason for this lack of consensus: a dearth of quality evidence in a scientific arena dominated by anecdote and laboratory experiment.

"Some of these practices that have been in place for decades haven't been subjected to the same strenuous investigation that, for instance, a new medicine might be subjected to," Mark Rupp, MD, president of the Society for Healthcare Epidemiology of America, told MedPage Today.

Masks, he noted, "are fairly innocuous, relatively cheap, and so people are not really very interested in going through the extensive investigation that would be required."

Conflicting Evidence

In the past two weeks, researchers have released results from the first two randomized clinical trials investigating efficacy of masks and respirators in protecting healthcare workers from respiratory infection.

Did they settle the issue?

Hardly. In fact, their conflicting results simply added fuel to the debate, according to CDC's Arjun Srinivasan, MD.

The first reports came in August, during IOM deliberations over standards for healthcare workers' personal protective equipment, when C. Raina MacIntyre, MBBS, PhD, of the University of New South Wales in Sydney, Australia, presented preliminary results of her randomized clinical trial.

That study involved nearly 2,000 emergency and respiratory ward nurses and physicians in Beijing who were cluster-randomized to wear surgical masks, fit-tested N95 respirators, or non-fit tested N95 respirators during all work hours for four consecutive weeks during the cold and flu season.

Having been through the SARS scare in 2003, the Chinese are regarded as very serious about mask use in the hospital and outside.

At the Interscience Conference on Antimicrobial Agents and Chemotherapy in September, MacIntyre presented the dramatic results: Consistent use of N95 respirators prevented 75% of respiratory infections, while consistent surgical mask use was no better than low use for prevention of clinical respiratory illness (6.7% versus 9.2%, P=0.159) or of influenza-like illness (0.6% versus 1.3%, P=0.336).

The case against old-fashioned surgical masks seemed clear.

"To me it would not seem justifiable to ask healthcare workers to wear surgical masks," MacIntyre said in an interview.

Then another shocker. A second head-to-head study appeared, this time in the Journal of the American Medical Association. It's conclusion: surgical masks were just as good as N95 respirators.

The 478 emergency department, medical unit, and pediatric nurses in this Canadian study who were randomized to use a surgical mask when providing care to patients with febrile respiratory illness during the flu season caught seasonal flu at about the same rate as those who wore fit-tested, N95 respirators (23.6% versus 22.9%, P=0.86).

For H1N1 influenza, surgical masks again met noninferiority criteria versus the N95 respirator (8.0% versus 11.9%, P=0.18).

Design may have accounted for the discrepancy between the trials, at least in part, suggested Srinivasan, who co-authored an editorial accompanying the JAMA study with an IOM committee member colleague.

"These types of studies are very difficult to do," he told MedPage Today.

The driving factor in effectiveness is how frequently and intensely the wearer is exposed to infection, he said. So one possibility is that masks may have been enough for Canadian nurses in generally lower risk settings, but not for the high-risk Chinese healthcare workers.

In Surgery: Masks Unmasked

Lack of evidence has also plagued surgical masks in their traditional setting, and where their use is still nearly universal: the operating room.

But not for lack of study.

In fact, three large, randomized controlled trials were conducted in the 1980s to determine once and for all if surgical masks actually did prevent surgical wound infection.

Here, where bacteria were the major concern in wound infection, the enemy targets were larger and might not require the fine filtration necessary to keep a respiratory virus away, researchers theorized.

But the trials "showed absolutely no efficacy" for that original purpose, MacIntyre noted.

"Really, the surgeon might as well wear nothing on their face," she said.

Still, the CDC recommends a mask in the operating room, citing long-standing tradition and the benefits of protecting nose and mouth from splashes of blood and other bodily fluids.

MacIntyre noted that a face shield is a better option against splashes because surgeons have to wear eye protection with a mask anyway.

But mask wearing "is so inculcated into the practice of medicine that it's going to be very hard to change," said John G. Bartlett, MD, former chief of infectious diseases at Johns Hopkins.

Tradition and aesthetics play a role in the issue. Patients would not accept a surgeon who doesn't wear a mask because they are so ingrained as a symbol of a safe surgical environment, Bartlett said.

And since the masks are fairly inexpensive and easy to wear, it hasn't been worth challenging the status quo, he declared.

Nor are there likely to be more studies to decide the issue one way or the other, added Rupp. "Those studies are difficult to do because the percentage of patients who develop a surgical site infection is very, very low. So the impact of wearing a surgical mask is difficult to demonstrate," he said.

Masks for the Masses

Unlike the operating room, where it would be impossible to stop people from wearing masks, there are few places outside the hospital where it hasn't been hard to persuade people to put them on.

One of the exceptions is Asia, which has developed has a strong culture of mask use, both in medical settings and in public venues, largely as a result of the SARS epidemic in 2003, Bartlett said.

"Those people did whatever they could to try to prevent SARS," he recalled. "If it turned out that the H1N1 virus became more virulent and started to be a really serious disease, then people would be much more fastidious about how they used the disease prevention tools."

The CDC recommends that people who are ill with suspected or confirmed H1N1 flu wear face masks when at home around family members, in healthcare settings, at school until they can be taken home, and when it's necessary for them to be out and about.

However, the only high-level evidence for efficacy of masks in the community was a trial from Hong Kong -- published online last month in the Annals of Internal Medicine  --  involving flu patients who were randomized to hand hygiene alone or in combination with surgical masks.

Compared with controls, employing hand hygiene alone or with face masks tended to reduce transmission of the flu to those living in the same house, but not significantly so.

However, when these interventions were initiated within 36 hours of symptom onset, face masks plus hand hygiene reduced risk of transmission by a very significant 67%.

Although the entire benefit can't be attributed to face masks, the results suggest masks may make a difference, MacIntyre said.

Because exposure to pathogens is typically much lower for the general public than for healthcare workers, "surgical masks may be enough in the community," she said.

Rupp agreed, saying he takes a "better safe than sorry" approach. His medical center asks patients with potentially droplet-mediated infections to put on a surgical mask.

"There probably isn't a whole lot of extensive study on the use of this in clinical situation," Rupp said. "We do think it's a pretty obvious way somebody can go about containing their secretions."

N95 masks would likely provide even more protection, MacIntyre said, but there's is fairly clear consensus that they would be intolerable for someone with a respiratory illness.

"They are relatively difficult to breath through; they can be associated also with feelings of claustrophobia and kind of a suffocating sensation," Rupp added. "It's difficult enough to get them to wear a loose fitting and relatively comfortable surgical mask."

Practical Masking

Practical issues such as compliance and supply have been part of the argument for use of surgical masks rather than N95 respirators in most clinical settings.

In a New England Journal of Medicine perspective piece last week, several IOM committee members acknowledged that N95 respirators are currently in short supply.

They suggested that healthcare institutions place priority on N95 respirators in the highest-risk areas, "such as enclosed spaces in the respiratory care unit, patients' rooms, and ambulances."

While the IOM was instructed to not take these issues into consideration in its guidelines, a CDC spokesperson said that agency is making them a large factor in revision of its interim guidelines for healthcare worker respiratory protection.

In the end, however, infectious disease specialists always come back to the bigger picture.

Debate over the role of respiratory protection in preventing influenza transmission doesn't "excuse anyone from failing to implement other measures that are known to protect patients and healthcare professionals from influenza," Srinivasan's JAMA editorial concluded.

"Masks and respirators should be considered the 'last line of defense' in a hierarchy of infection control measures."

Handwashing, good etiquette when sneezing and coughing, and staying home when sick are still the keys to preventing spread of infectious disease, it said.

#Coronavirus #maskingtape #covid_19 #health #surgical mask

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Physically The Cause Can Be Medication

Like the new research, they found Viagra targeted problems from the genetic mutations, although inflammation also dropped. Citrulline is found in all colours of watermelon and is highest in the yellow-fleshed types, said Penelope Perkins-Veazie, a USDA researcher in Lane, Okla. However, the problem with this natural remedy, is that, it can generate some negative side effects just like Viagra can. However, it is always best to consult your doctor regarding the required dose per day. The evening belongs, however, by the lovely belly-dancing ladies who can show you a move or two! Rosen and a team of investigators from NYEE based their study on a 31-year-old patient who arrived at an urgent care clinic complaining of red-tinted vision in both eyes that hadn't gone away in two days. Viagra for women is normally delivered within 4 -12 working days from the date of payment. They conclude that using higher doses of Viagra could eventually lead to significant long-term vision damage. Our study uses much lower doses of sildenafil over a shorter period than the Dutch trial. In the mouse model, small doses of Viagra reduced the formation of polyps by 50 percent. The Food and Drug Administration (FDA) is advising consumers not to purchase or use Maximum Powerful, a product promoted for sexual enhancement that contains sildenafil, the active ingredient in Viagra. But new, preliminary research finds that coating stents with a drug normally used for treating erectile dysfunction may prevent the arteries from clogging or narrowing again. For some patients, stents reduce the risk of "restenosis" - the renarrowing of arteries. In medicine, there is this “dose relationship” effect which says the more of disease-causing drug is ingest the greater the risk of developing that affliction. Of course, in the case of people prone to having clogged arteries, doctors may prescribe anti-platelet drugs to reduce the risk of a heart attack or stroke. People with an APC genetic mutation might develop hundreds of colorectal polyps, which may eventually result in cancer. The same team would have failed if they came forward with a random machine learning idea that conceptually might make sense but didn’t fit Evite’s objectives. This was the conclusion that researchers at the University of Ottawa in Canada came to after they tested the effect of tadalafil (Cialis), sildenafil (Viagra), and an inactivated version of the flu vaccine Agriflu in mouse models of post-surgery metastasis. The damage was similar to that seen in animal models of hereditary retinal disease such as retinitis pigmentosa or cone-rod dystrophy. Using these techniques, the team looked in detail at the cellular makeup of the man's retina and investigated it for Viagra-induced damage. The scientists also looked at the prescription drug linaclotide, which is used to treat constipation and irritable bowel syndrome with constipation and, like Viagra, is known to increase cyclic GMP. Men with erectile dysfunction are now going to be able to buy Viagra over the counter after health officials reclassified the drug. The ACC also leads the formulation of important cardiovascular health policy, standards and guidelines. To stay ahead in the competition that involves many online Viagra vendors, different tools like keywords optimization, back links etc have been incorporated. Commonly referred to as a wonder drug, Viagra was initially developed to treat high-blood pressure and chest pain, but soon showed that it could also combat erectile dysfunction. Viagra is best known for its ability to relax the smooth muscle cells around blood vessels so the vessels can more easily fill with blood, which is how it helps both erectile dysfunction and pulmonary hypertension. Sildenafil is so helpful in treating erectile dysfunction and hypertension because it relaxes smooth muscle cells around blood vessels, allowing blood to more easily move into them. Surgery with no drugs or vaccine resulted in 129 metastases. Maybe they don't believe drugs or they are healthy. What are those diseases? Its worldwide prevalence is 15.5%, comprising about 20 million children born each year, but the vast majority of low-birth-weight cases — 96.5% — are in developing countries. These products are labeled as generic Viagra or herbal Viagra in order to cash in on the brand recognition that Viagra has. Cho immediately greenlit the idea. The research centers on the idea that increased levels of a chemical called cyclic GMP has been seen to suppress some intestinal cancers by reducing excessive cell proliferation in the gut. The basic idea is the medicine weakens the crown of each individual sperm. Medications that contain nitrates can increase the likelihood of side effects and complications in the body. The drug seemed to slightly increase fetal growth, so they drew up plans for a larger, international trial spanning Canada, New Zealand, Australia, the U.K. This means that performance becomes even less as the person becomes dependent on taking the drug. “It was all spam.” So, Evite took steps to address it even though it meant taking a short-term hit. The 31 year-old man, who took the medication to help his erectile dysfunction, was admitted to hospital. These come as patches, tablets for sucking, sprays for inhalation or as solutions for intravenous use in hospital. Today, it is used to help diagnose conditions such as glaucoma and diabetic retinopathy. Making me sometimes run out of breath before I reached the end of the sentence. We’re making a running list of the widespread complaints about the new phones, online pharmacies and we encourage you to add your own grievances in the comments. “We’ve been getting the love fumes for years now for free,” added Debbie’s mother, Sadie. In Port Douglas I went through a trial and error routine of getting used to Sinemet and getting the dosage right.

[myabhijitr]

Plasmid DNA Manufacturing Market Size Is Estimated To Reach USD 2,733.8 Million with Exhibit a 23.2% CAGR by 2028 | Future Business Opportunities and Industry Insights | Cobra Biologics, VGXI, Aldevron

The global plasmid DNA manufacturing market is probably going to grow within the estimated period thanks to the growing number of patients choosing gene therapy. as an example, as of November 2017, approximately 2,600 gene therapy clinical trials were either ongoing, completed, or approved in 36 countries, per data published by the Journal of Gene Medicine in March 2018. The countries where the tests were conducted are Kingdom of The Netherlands, Switzerland, Japan, Germany, France, China, Canada, Australia, UK, US, and others. Furthermore, diseases targeted by gene therapy count neurological diseases, eye diseases, severe combined immunodeficiency (SCID), haemophilia A and B, inflammatory and infectious diseases, cancer, cardiovascular diseases, and others.

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The number of Kovid-19 infections is on the increase globally, resulting in fears of a shortage of life-saving equipment and other essential medical supplies to forestall the spread of the epidemic and supply optimal care to those affected. Furthermore, until pharmacological treatment is developed, ventilators function a vital treatment priority for COVID-19 patients who may require serious care. Currently, there’s an urgent have to accelerate the manufacturing process to develop a good range of test kits (antibody tests, self-administered and others).

Major players working within the market are specializing in the event of DNA vaccines for the treatment of COVID-19. In April 2020, INOVIO Pharmaceuticals Inc. German contract manufacturer Richter-Helm BioLogics GmbH & Co. to support production of INOVIO’s investigative DNA vaccine. Agreed to expand production partnership with KG, which is currently INO-4800. Phase 1 clinical trials for Covid-19 treatment within the US and Phase 2/3 efficacy tests within the summer of April 2020 could potentially move forward. Increasing government efforts to combat Kovid-19 will help speed up the epidemic. as an example, in March 2020, the US announced a US $ 2.9 million assistance package to India to assist the govt. of India develop laboratory systems, activate case detection and event-based surveillance, and assist technical experts in response and preparation. this is often a part of the US Global Aid Program to fight COVID-19.

Global Plasmid DNA Manufacturing Market: Drivers

The key players are specializing in various inorganic growth strategies like collaboration, which is probably going to drive growth within the global plasmid DNA manufacturing market over the estimated period. as an example, Biomay, CDMO, and BIA Separations, a number one bio chromatography development and manufacturing company, entered into a cooperation agreement to co-develop financial production systems in May 2018, for the assembly and refining of enormous DNA plasmids.

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The size of the worldwide Plasmid DNA Manufacturing Market is probably going to witness a CAGR of 23.2% during the estimated period because of the adoption of inorganic growth strategies like market share of major players, the worldwide plasmid DNA manufacturing market is probably going to grow within the estimated period. as an example, in June 2017, Alma Bio Therapeutics SAS (Alma) and Delphi Genetics expanded their strategic alliance (partnership) to develop plasmid DNA drugs. Under this alliance, Delphi Genetics created plasmid DNA for the Alma Biotherapy SAS pipeline.

Depending on the kind of product, the Plasmid DNA segment is probably going to exhibit high CAGR within the global plasmid DNA manufacturing market over the estimated period. for instance, Cobra Biologics is developing pDNA for a spread of clinical applications within the UK, in keeping with world organization (EU) clinical trials guidelines. the corporate has developed its own production process for the purification and production of pDNA, including technology associated with cell-lysis technology, operator repressor titration (ORT), and antibiotic-free plasmid maintenance systems.

In terms of the event phase, pre-clinical therapeutics is probably going to dominate the worldwide plasmid DNA manufacturing market by 2021. Increased research and development activities for the event of novel plasmid DNA are likely to extend the segmentation during this estimated period. as an example, Applied DNA Sciences Inc., the leader in large-scale polymerized chain reaction-based DNA production, announced that its wholly-owned subsidiary LineaRx Inc, specializing in next-generation biotherapeutics, has begun pre-clinical development of a non-viral, plasmid. -Free (NVPF) chimeric antigen receptor (CAR) modified T lymphocyte (CAR T) production platform available to CAR-T developers worldwide in October 2018.

Among the regions, North America is probably going to dominate the worldwide plasmid DNA manufacturing market by 2021. thanks to the presence of key players within the region, North America expects significant growth in markets that specialize in expanding facilities. Production and research and development activities. as an example, VGXI Inc. has announced the launch of a novel facility to expand its bio-production services in November 2018, including space for flexible scale plasmid DNA production still as GMP production areas for RNA synthesis.

Competitive Landscape

Key players performing in the Global Plasmid DNA Manufacturing Market are Geneone Life Science, Puresyn Inc., Altogen Biosystems, Genopis Inc., Synbio Technologies, Ajinomoto Bio-Pharma Services, Luina Bio Pvt Ltd, Greenpak Biotech Ltd, Lonza, GeneImmune Biotechnology Corp., Biomiga, Delphi Genetics, Cepham Life Sciences, JAFRAL Ltd., Biomay, Akron Biotech, Creative Biogene, GENEWIZ, Genscript Biotech Corporation, Luminous BioSciences (LBS) LLC, Vigene Biosciences, MeiraGTx Limited, LakePharma Inc., Waisman Biomanufacturing, Cell and Gene Therapy Catapult, PlasmidFactory GmbH & Co. KG, Nature Technology Corporation, Kaneka Corporation, Aldevron, VGXI Inc., and Cobra Biologics and Pharmaceutical Services*.

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Guidelines for Effective Dietary Management of Fructose Malabsorption: The Minimal FODMAP Diet

Sensitivity to carbs like lactose, fructose and sorbitol are largely undiagnosed, but responsible for stomach bloating and abdominal hardship to many. A group of indigestible carbohydrates or carbs, including oligosaccharides, disaccharides, monosaccharides and polyols have already been proven to be osmotically active, fast fermenting in the gastrointestinal tract. Numerous studies show these carbs are substantial sparks of gastrointestinal indicators in patients with fructose malabsorption and IBS separately or in combination.

The low FODMAP diet has substantially improved the gastrointestinal wellness of numerous with fructose malabsorption and annoying bowel syndrome in clinical trials. FODMAPs symbolize the food forms which are many prone to fermentation by the stomach bacteria. Evidence implies that reducing worldwide absorption of FODMAPs to manage useful stomach indicators gives sign comfort for about 75% of patients with FGDs such as annoying bowel syndrome. Practical stomach indicators vary from individual to person. Treating useful stomach problems varies. Adjustment of meal measurement, liquor, fat and caffeine plays an essential role. Use of adequate levels of fibre and plenty of new natural water often helps substantially in controlling and maintaining healthy digestive health. Recognition of the medial side results that get along with products and medications is really a must. Life style changes that gain digestion including pleasure, exercise, proper rest and sunlight are also essential key elements along with administering the Reduced FODMAP diet.

That band of poorly absorbed, short-chain carbohydrates, referred to as the FODMAPs was manufactured by analysts from Australia, Doctor Sue Shepherd and Professor Peter Gibson. They coined the word FODMAPs as a means to sort an otherwise unrelated band of specific kinds of carbohydrates. The acronym FODMAPs represents Fermentable Oligosaccharides, Disaccharides and Monosaccharides. It's applied to establish an otherwise unrelated band of small chain carbohydrate and sugar alcohols. The FODMAPs are fermented by the bacteria of the intestines resulting in flatulence, pain, bloating, reflux, diarrhea and constipation.

By reduction of nutritional FODMAPs it is visible that there is accomplishment in giving rest NDF-Wiedereinführung from these indicators to the majority of individuals with fructose malabsorption and comfort to some with annoying bowel syndrome. Fructose is only 1 of the numerous poorly absorbed, short-chain carbohydrates that cause the apparent symptoms of fructose malabsorption. They are complex names for an accumulation molecules found in food which are poorly absorbed by some people. When these molecules are poorly absorbed in the little intestine, they act as a food supply to the bacteria in the intestinal tract, causing large osmotic activity and quick fermentation which then leads to luminal distension and the prospect of future sign induction in individuals with less versatile bowels or visceral hypersensitivity.

In the in-patient fermenting short-chain carbohydrates like fructose and lactose might be malabsorbed, polyols are often poorly absorbed and fructans and galactans are always poorly absorbed in most individuals. Consuming meals high in FODMAPs benefits in improved level of water and gas in the little and big intestine, leading to distention and indicators such as abdominal pain and gas and bloating.

People that have fructose malabsoption show good improvement by being on the Reduced FODMAP diet. Lots of people knowledge a larger quality of life from being with this diet. That diet does need a few nutritional changes. Prior to starting, you must consult a registered nutritionist or dietitian to greatly help guarantee you are finding the right nutrition including fiber. It can also be essential and highly relevant to recognize that FM can co-exist with intolerance to different food substances including chemicals, salicylates, amines, lactose or gluten so it is vital that you look closely at these in the event that you however are encountering indicators when following a diet. Studies are still being done (currently at Monash College in Australia) on meals within the FODMAP diet. That diet is still in their infancy. New research is going to be revealed as time moves ahead and more testing is done.