![]() General: In the US, all the drugs should be approved by the Food and Drug Administration for certain indications.Preclinical studies do not include human subjects. Large number of patients with a specific disease after drug approvalīefore clinical trials begin, drugs are first tested in preclinical studies.evaluation of rare and long-term side effects) Safety studies following approval (esp.Postmarketing surveillance: compares the real-life efficacy to that described in research studies.Randomized control trial with a large number of patients with a specific disease ( ∼ 100–1000).Final confirmation of safety and evaluation of efficacy against placebo or the current standard of care.Moderate number of patients with a specific disease ( ∼ 10–100).Evaluation of efficacy, optimal dose range, and side effects (esp.Small number of healthy individuals or patients with a specific disease ( ∼ 15–30 ).Evaluation of the maximum tolerated dose.Evaluation of pharmacodynamic and pharmacokinetic properties of the drug, safety and toxicity.Small sample: consisting either healthy individuals or of population with a disease of interest ( ∼ 10–15).Only Exploratory phase with no therapeutic or diagnostic intent with the aim of gaining insight on pharmacokinetics and pharmacodynamics.
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