title: Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation.
abstract: 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.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. issam.zineh@fda.hhs.gov
authors.forename: I
authors.initials: I
authors.lastname: Zineh
authors.forename: J
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D006801:Humans; D058436:Knowledge Management; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration