The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop-Reference-Cited by-同舟云学术

The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop

Published:2013-02 Issue:2 Volume:2 Page:31
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT: Pharmacometrics & Systems Pharmacology

Author:

Manolis E¹,Rohou S²,Hemmings R¹³,Salmonson T¹⁴,Karlsson M⁵,Milligan PA⁶

Affiliation:

1. European Medicines Agency (EMA); London UK

2. Global Medicines Development, Regulatory Affairs, AstraZeneca R&D; London UK

3. Medicines and Healthcare products Regulatory Agency (MHRA); London UK

4. Swedish Medical Products Agency (MPA); Uppsala Sweden

5. Department of Pharmaceutical Biosciences; Uppsala University; Uppsala Sweden

6. Pfizer, Pharmacometrics, Global Clinical Pharmacology; Sandwich UK

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1038/psp.2013.7/fullpdf

Reference10 articles.

1. European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop report http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/05/WC500127118.pdf

2. Model-based drug development - a new paradigm for efficient drug development;Kowalski;Biopharmaceut Report,2007

3. The productivity crisis in pharmaceutical R&D;Pammolli;Nat. Rev. Drug Discov.,2011

4. Arrowsmith , J. Trial watch: Arrowsmith, J. Phase II failures: 2008-2010 Nat. Rev. Drug. Discov. 2011 Nat. Rev. Drug. Discov

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