SCIE 1P51 Lecture Notes - Lecture 21: Irving Kirsch, Pharmacokinetics, Health Canada
16 Sep 2016
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Phase 1 testing: interaction studies food, other medications, looking for healthy volunteers, 1 year, 3-5 compounds enter trial. No company will put all hopes in one compound as there is the chance it will fail; having back compounds betters their chances pharmacokinetics - study of the absorption, distribution, metabolism and elimination of drugs. Phase 2 testing: 100-300 subjects, short term effectiveness first phase is based upon safety second phase focuses in on side effects, 2 years, 3-5 compounds enter trial, trials use subjects with specific target diseases. Phase 3 testing: has to be tested on large populations, 1000-3000 patients, verify & long-term, 3 years, 3-5 compounds enter trial. Phase 5 testing: just been approved, further trials & monitoring, given free samples. ***phase 4/5 - physicians may be asked by drug companies for access to effects and acceptance of drug by patients. Drug action producing some effect: how does the effect physically work on the body, great way of classifying drugs.
