BPS 2110 Study Guide - Midterm Guide: Fluconazole, Dd-Transpeptidase, Reaction Rate Constant

• School: University of Ottawa
• Department: Biopharmaceutical sciences
• Course: BPS 2110
• Professor: Robert Ben

Document Summary

The pharmaceutical industry: multi-billion dollar industry, highly regulated, more than any other industry, fda, health canada, u takes (cid:1005)/(cid:1006) of i(cid:374)dustr(cid:455), e(cid:448)er(cid:455)o(cid:374)e else (cid:272)opies u fda (cid:373)ore i(cid:373)pt. Satisfy fda, satisfy anyone: research intensive, high risk, high profit. Costs to develop a new drug (us millions: 1975 - 138, 1987 - 318, 2001 - 802, 2005 - 1300, total r&d spending over 50 billion per year (phrna member companies) Fda approval: 6 months to 1. 5 years, market. Identified after 1-3 years of research: heavily driven by chem and biochem, synthesis and testing of up to 5000 new compounds. Structure is kept secret: no approval necessary for further testing. New drug application (nda: application made to the fda to enter market, safety of drug, efficacy of drug, benefits outweigh the risks, appropriate labelling, what it should contain, manufacturing methods are sound, controls in place to maintain quality.