PCL201H1 Lecture Notes - Lecture 29: Lead Compound, Drug Development, Adme
14 Sep 2016
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Each country has its own regulatory authorities: us: fda, can: tpd, bgtd, nhpd. Drug development takes 10-12 years and up to billion: discovery. 1-2 years, ,000: ethics search for a lead compound, optimization, in-vitro testing. Nuremberg doctors trial (1946) = nuremberg code (1949) (cid:862)i(cid:374)for(cid:373)ed (cid:272)o(cid:374)se(cid:374)t(cid:863) In canada, clinical trials must be approved by the reb: health canada. Tpd reviews protocols for phase i to iii studies though a clinical trial application (cta) process. Tpd issues no objection letter to authorize phase i: phase i. Maybe also try to establish adme (cid:862)(cid:271)li(cid:374)ded(cid:863: phase ii. Meeting with fda to proceed to phase iii: phase iii. Verify safety and efficacy in large populations. Submit data to fda: new drug submission/application. File nds (100,000 pages of common technical document); 3 possible outcomes: not approvable, approvable, approval letter (noc, abbreviated new drug submission. Generic drugs only need to show bioequivalence. Compare how well it stands on the market with other drugs.
