NEU 365D Lecture Notes - Lecture 19: Phocomelia, Pharmacokinetics, Pharmacodynamics
Document Summary
10/14 - lecture 19: adr (adverse drug reactions) Not all drugs that are approved by the fda are understood (mechanistically how it works): animals selected populations (efficacies/pharmacological profiles - clinical trials) Some adverse effects are detected in pre-market studies (common ones) Rare adverse drug effects can be detected after the drug comes to market and is used by large number of patients over a long period of time. Costs between 1-2 billion to develop a drug (sometimes 5) Effects on rats may differ from those on humans. Ex: thalidomide (hypnotic) disaster of 1961 - pattern of birth defects. Used to help pregnant women sleep & as an anti-nausea agent. Phocomelia - upper part of the limb absent/poorly developed. Use in 3rd trimester - when forelimb buds were develop. Re-evaluation of the methodology and regulations applied to the testing of the safety of drugs. In vitro & in vivo in animals (tissue cultures)
