Next-generation medicines: Past regulatory experience and considerations for the future

Clinical Pharmacology and Therapeutics

Volumn 95, Issue 3, 2014, Pages 247-249

  Pacanowski, M A ^a   Leptak, C ^a   Zineh, I ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANIMALS; DRUG DELIVERY SYSTEMS; DRUG THERAPY; HUMANS; INDIVIDUALIZED MEDICINE; LEGISLATION, DRUG; MEDICAL INFORMATICS; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84894491134     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.222     Document Type: Review

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4. US Food and Drug Administration. Guidance for Industry -Clinical Pharmacogenomics: Premarket Evaluation in Early Phase Studies and Recommendations for Labeling (January 2013).
5. Zineh, I. & Woodcock, J. Clinical pharmacology and the catalysis of regulatory science: opportunities for the advancement of drug development and evaluation. Clin. Pharmacol. Ther. 93, 515-525 (2013).
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