BPS 2110 Lecture Notes - Lecture 1: Aripiprazole, Schizophrenia, Stereochemistry

92 views7 pages

Document Summary

The pharmaceutical industry: multi-billion dollar industry, highly regulated, more than any other industry, fda, health canada, us takes (cid:1005)/(cid:1006) of i(cid:374)dustry, e(cid:448)eryo(cid:374)e else (cid:272)opies us 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.

Get access

Grade+20% off
$8 USD/m$10 USD/m
Billed $96 USD annually
Grade+
Homework Help
Study Guides
Textbook Solutions
Class Notes
Textbook Notes
Booster Class
40 Verified Answers
Class+
$8 USD/m
Billed $96 USD annually
Class+
Homework Help
Study Guides
Textbook Solutions
Class Notes
Textbook Notes
Booster Class
30 Verified Answers

Related Documents