Clinical Trials | Different Phase of Clinical Trial | What is Clinical Trial | Clinical Pharmacology

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Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioural research studies on human participants are designed to answer specific questions about biomedical or behavioural interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

Phase 0- Phase 0 trials are optional first-in-human trials. 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 agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs

Phase 01- Often the first-in-man trials. Testing within a small group of people (typically 20–80) to evaluate the safety, determine safe dosage ranges, and begin to identify side effects. A drug's side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects.

Phase 02- Testing with a larger group of people (typically 100–300) to determine the efficacy and to further evaluate its safety. The gradual increase in test group size allows for the evocation of less-common side effects.

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 collect information that will allow it to be used safely.

Phase IV- Postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use. As such, they are ongoing during the drug's lifetime of active medical use

Description Credit- wikipedia

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[tusharthakur]

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[sanjibmishra]

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[sanjibmishra]

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