PCL102H1 Lecture Notes - Lecture 2: Pharmacovigilance
26 Feb 2020
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Pcl102 lecture 2 - drug discovery pipeline unmet medical need - condition whose treatment or diagnosis is not addressed adequately by available therapy. Includes: an immediate need for a de ned population (e. g. , to treat a serious condition with no or limited treatment) a longer-term need for society. Novelty: me-too drug: a drug already exists to treat the disease by addressing the same target. Phase 3 clinical trials: objective - to compare ef cacy of new treatment with standard regimen, design - usually randomized control subjects - patients with the disease, main clinical trials are phase 3 addition - establish optimal dosage. Phase 4 clinical trials: pharmacovigilance - monitoring of drug safety under actual conditions of use in large.
