A proposal for scientific framework enabling specific population drug dosing recommendations

Journal of Clinical Pharmacology

Volumn 55, Issue 10, 2015, Pages 1073-1078

  Jadhav, Pravin R ^a   Cook, Jack ^b   Sinha, Vikram ^c   Zhao, Ping ^c   Rostami Hodjegan, Amin ^d   Sahasrabudhe, Vaishali ^b   Stockbridge, Norman ^c   Powell, J Robert ^e  

^a MERCK RESEARCH LABORATORIES   (United States)

^b PFIZER INC   (United States)

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

^d UNIVERSITY OF MANCHESTER   (United Kingdom)

^e Independent Consultant   (United States)

Author keywords

clinical pharmacology; dosing and administration; drug approval; drug development; labeling; modeling and simulation; specific populations

Indexed keywords

ARTICLE; CONCEPTUAL FRAMEWORK; DOSE; DOSING RECOMMENDATION; DRUG APPROVAL; DRUG CLEARANCE; DRUG LABELING; DRUG LEGISLATION; HUMAN; POPULATION; POPULATION AND POPULATION RELATED PHENOMENA; PREDICTION; SIMULATION; BIOLOGICAL MODEL; COMPUTER SIMULATION; DOSE RESPONSE; DRUG THERAPY; PHARMACOKINETICS;

COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG LABELING; DRUG THERAPY; HUMANS; LEGISLATION, DRUG; MODELS, BIOLOGICAL; PHARMACOKINETICS;

EID: 84940887616     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.579     Document Type: Article

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