Modeling and Simulation in Clinical Pharmacology and Dose Finding

Author:

Staab A1,Rook E23,Maliepaard M23,Aarons L4,Benson C5

Affiliation:

1. Translational Medicine, Pharmacometrics, Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach Germany

2. Medicines Evaluation Board, Graadt van Roggenweg; Utrecht The Netherlands

3. European Medicines Agency; London UK

4. School of Pharmacy and Pharmaceutical Sciences, The University of Manchester; Manchester UK

5. Eli Lilly, Lilly Corporate Center; Indianapolis Indiana USA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Reference10 articles.

1. Model-based drug development survey finds pharmacometrics impacting decision making in the pharmaceutical industry;Stone;J. Clin. Pharmacol.,2010

2. Model-based drug development;Lalonde;Clin. Pharmacol. Ther.,2007

3. Role of modelling and simulation: a European regulatory perspective;Jönsson;Clin. Pharmacokinet.,2012

4. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008;Lee;Clin. Pharmacokinet.,2011

5. European Medicines Agency Draft concept paper: Concept paper on extrapolation of efficacy and safety in medicine development http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129285.pdf

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