Utility of Model-Based Approaches for Informing Dosing Recommendations in Specific Populations: Report From the Public AAPS Workshop

Journal of Clinical Pharmacology

Volumn 57, Issue 1, 2017, Pages 105-109

  Younis, Islam R ^a   Robert Powell, J ^b   Rostami Hodjegan, Amin ^c   Corrigan, Brian ^d   Stockbridge, Norman ^a   Sinha, Vikram ^e   Zhao, Ping ^a   Jadhav, Pravin ^f   Flamion, Bruno ^g,h   Cook, Jack ^d  

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

^b University of Manchester ^*  (United States)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d PFIZER INC   (United States)

^e MERCK RESEARCH LABORATORIES   (United States)

^f OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC   (United States)

^g UNIVERSITY OF NAMUR   (Belgium)

^h EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

dosing recommendations; modeling and simulation; specific population

Indexed keywords

ARTICLE; CLINICAL PATHWAY; DRUG DOSE REGIMEN; DRUG INDUSTRY; DRUG LABELING; FOOD AND DRUG ADMINISTRATION; HUMAN; PUBLIC-PRIVATE PARTNERSHIP; RECOMMENDED DRUG DOSE; WORKSHOP; BIOLOGICAL MODEL; EDUCATION; FLORIDA; MEDICAL RESEARCH; METABOLISM; PROCEDURES; RESEARCH; TRENDS;

DRUG;

BIOMEDICAL RESEARCH; DRUG INDUSTRY; EDUCATION; FLORIDA; HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; RESEARCH REPORT;

EID: 84985920001     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.787     Document Type: Article

References (4)

1. Jadhav PR, Cook J, Sinha V, et al. A proposal for scientific framework enabling specific population drug dosing recommendations. J Clin Pharmacol. 2015;55(10):1073–1078.
2. Innovative Medicines Initiative. http://www.imi.europa.eu/
3. International Consortium for Innovation and Quality in Pharmaceutical Development. https://iqconsortium.org/
4. Critical Path Institute. http://c-path.org/