Safety of Drugs is, Indeed, a Lifecycle Exercise
The recent eCliniqua article McClellan Envisions Lifecycle Approach to Drug Surveillance reminded me of some thoughts I’ve held regarding the safety of pharmaceutical compounds for quite some time [see ref. 1]. Whereas establishing efficacy of a drug for a particular indication may end with the submission and FDA approval of the new drug application (NDA), monitoring drug safety is, indeed, a lifecycle exercise. Safety and efficacy data—pre- and post-market approval—on pharmaceutical compounds are among the most valuable resources of the pharmaceutical industry. Drugs in development proceed according to two axioms of drug development : A drug that has been elevated to clinical development status continues in development until the null hypothesis of safety is contradicted, or until the null hypothesis of inefficacy is contradicted.
Peace, Karl E..
"Safety of Drugs is, Indeed, a Lifecycle Exercise."