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7314157 
Journal Article 
Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation 
Zineh, I; Woodcock, J 
2013 
Yes 
Clinical Pharmacology & Therapeutics
ISSN: 0009-9236
EISSN: 1532-6535 
93 
6 
515-525 
English 
23571772 
WOS:000319304800022 
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. 
aflibercept; axitinib; belatacept; belimumab; boceprevir; bosutinib; cabozantinib; carboxypeptidase G2; carfilzomib; choline c 11; cobicistat plus elvitegravir plus emtricitabine plus tenofovir disoproxil; crizotinib; dabigatran; enzalutamide; florbetapir f 18; homoharringtonine; ipilimumab; ivacaftor; lucinactant; ocriplasmin; pertuzumab; ponatinib; regorafenib; roflumilast; taliglucerase alfa; telaprevir; unindexed drug; vemurafenib; vilazodone; vismodegib; article; catalysis; clinical pharmacology; drug activity; drug approval; drug control; drug development; drug efficacy; drug industry; drug marketing; drug safety; drug screening; drug targeting; food and drug administration; human; molecularly targeted therapy; nonhuman; pharmacogenomics; priority journal; risk benefit analysis; Drug Approval; Drug Discovery; Drug Industry; Humans; Knowledge Management; Pharmacology, Clinical; United States; United States Food and Drug Administration