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U.S. Department of Health and Human Services

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Clin Pharmacol Ther 2013 Jun;93(6):515-25

Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation.

Zineh I, Woodcock J


The "regulatory paradox" is a tension between aversion to uncertainty and willingness to accept unknowns about a drug before its approval. Finding the right balance may mean the difference between fostering and stifling innovation. Clinical pharmacology applied in the drug development and regulatory contexts can bridge mechanistic reasoning and empiricism to help reconcile the regulatory paradox. Here, we propose that the discipline of clinical pharmacology, in the regulatory setting, is well positioned to build on its past successes in the advancement and acceleration of drug development.Clinical Pharmacology & Therapeutics (2013); advance online publication 10 April 2013. doi:10.1038/clpt.2013.32.

Category: Journal Article
PubMed ID: #23571772 DOI: 10.1038/clpt.2013.32
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2013-04-11 Entry Last Modified: 2013-07-10