Biostatistics: Faculty Publications

Safety of Drugs is, Indeed, a Lifecycle Exercise

Document Type

Article

Publication Date

7-21-2008

Publication Title

Bio-IT World

Abstract

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 [2]: 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.

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