Course Content
Topic outline
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Drug Discovery : the series of activities involved in identifying a novel drug candidate.
Target Discovery : identification of novel pathways that play an important role in the pathogenicity or progression of a disease.
Drug Development : comprises all activities involved in transforming a drug candidate to a product approved for marketing.
Preclinical Development : activities that link drug discovery to initiation of human clinical trials.
Hits : potential drug candidates that can modulate disease pathway.
Lead Candidate : a refined hit.
IND application : Investigational New Drug application package summarizes the results of the preclinical studies for submission to FDA/other regulatory authorities.
Observational studies : in these studies, investigator observes individuals without manipulation or intervention.
Clinical Trials : studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.
Phase I clinical trials : provide initial safety data to support further testing with a larger number of people.Pharmacokinetic data : data to assess the rates of absorption and elimination in humans.
Phase II clinical trials : seek further safety data and preliminary evidence in support of biological effect or efficacy.
Phase III clinical trials : large confirmatory studies meant to establish an acceptable benefit/safety profile in order to gain regulatory approval for a precisely defined indication.
Phase IV clinical trials : evaluate rare but serious effects that occur over time by a new treatment after it has been approved and is on the market.
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