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.
| Original language | American English |
|---|---|
| Journal | Bio-IT World |
| State | Published - Jul 21 2008 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Disciplines
- Biostatistics
- Public Health
- Community Health
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