Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 41, Issue 6, 2014, Pages 545-552

  Romero, Klaus ^a   Sinha, Vikram ^b   Allerheiligen, Sandra ^c   Danhof, Meindert ^d   Pinheiro, Jose ^e   Kruhlak, Naomi ^b   Wang, Yaning ^b   Wang, Sue Jane ^b   Sauer, John Michael ^a   Marier, J F ^f   Corrigan, Brian ^g   Rogers, James ^h   Lambers Heerspink, H J ⁱ   Gumbo, Tawanda ^j   Vis, Peter ^k   Watkins, Paul ^l   Morrison, Tina ^b   Gillespie, William ^h   Gordon, Mark Forrest ^m   Stephenson, Diane ^a   Hanna, Debra ^a   Pfister, Marc ⁿ   Lalonde, Richard ^g   Colatsky, Thomas ^b   more..

^a CRITICAL PATH INSTITUTE   (United States)

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

^c MERCK RESEARCH LABORATORIES   (United States)

^d LEIDEN UNIVERSITY   (Netherlands)

^e Janssen   (United States)

^f CERTARA   (United States)

^g PFIZER INC   (United States)

^h Metrum Research Group LLC   (United States)

ⁱ UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^j UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^k LAP P Consultants BV   (Netherlands)

^l HAMNER INSTITUTES FOR HEALTH SCIENCES   (United States)

^m BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

ⁿ UNIVERSITY OF BASEL   (Switzerland)

more..

Author keywords

(Q)SAR; Biostatistics; Modeling and simulation; Pharmacometrics; Pre competitive research; Quantitative drug development; Regulatory science

Indexed keywords

ARTICLE; CLINICAL PATHWAY; DECISION MAKING; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG SCREENING; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; MEDICAL PRODUCT DEVELOPMENT; MOLECULAR DOCKING; MOLECULAR MODEL; SCIENTIST; WORKSHOP; BIOLOGICAL MODEL; CHEMISTRY; COMPUTER SIMULATION; HUMAN; PROCEDURES; THEORETICAL MODEL; UNITED STATES;

DRUG;

COMPUTER SIMULATION; DECISION MAKING; DRUG DISCOVERY; HUMANS; MODELS, BIOLOGICAL; MODELS, THEORETICAL; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84912050269     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-014-9390-0     Document Type: Article

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