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Experimental animal – https://www.youtube.com/watch?vkAxTbc6nsFs
Preclinical research – https://www.youtube.com/watch?vMZn0tGvc0Yg
Drug Discovery Phases – https://www.youtube.com/watch?vrQZmJz8VW7I
Therapeutic index- https://www.youtube.com/watch?vm-915T9183Q
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Clinical trials are experiments or observations conducted in clinical research. Such prospective biomedical or behavioral studies of human participants are intended to answer specific questions about biomedical or behavioral interventions, including new treatments (such as new vaccines, drugs, dietary choices, nutritional supplements, and medical devices) and known interventions that warrant further investigation. and comparison. Clinical trials generate data on safety and efficacy. They are only carried out after receiving approval from the health authority/ethics committee in the country where approval for the therapy is sought. These authorities are responsible for assessing the risk-benefit ratio of the research. Their approval does not mean that the therapy is 'safe' or effective, but only that the research may be conducted.
Phase 0- Phase 0 studies are optional first-in-human studies. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (typically 10 to 15) to gather preliminary data on the drug's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the medications).
Phase 01 – Often the 'first-in-man' trials. Testing within a small group of people (typically 20-80) to evaluate safety, determine safe dosage ranges, and identify side effects. The side effects of a drug may be subtle or long-lasting, or may only affect a few people. Therefore, phase 1 trials are not expected to reveal all side effects.
Phase 02 – Testing in a larger group of people (typically 100–300) to determine efficacy and further evaluate its safety. The gradual increase in the size of the test group ensures that fewer common side effects may occur.
Phase 03 – Testing with large groups of people (typically 1,000–3,000) to confirm its efficacy, evaluate its effectiveness, monitor side effects, compare it to commonly used treatments, and gather information that will allow it to be used safely.
Phase IV Postmarketing studies provide additional information including the risks, benefits, and optimal use of the treatment. As such, they are ongoing throughout the life of active medical use of the drug
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