Modeling and Simulation to Optimize the Design and Analysis of Confirmatory Trials, Characterize Risk-Benefit, and Support Label Claims-Reference-Cited by-同舟云学术

Modeling and Simulation to Optimize the Design and Analysis of Confirmatory Trials, Characterize Risk-Benefit, and Support Label Claims

Published:2013-02 Issue:2 Volume:2 Page:27
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT: Pharmacometrics & Systems Pharmacology

Author:

Marshall SF¹,Hemmings R²³,Josephson F²⁴,Karlsson MO⁵,Posch M²⁶,Steimer J-L⁷

Affiliation:

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

2. European Medicines Agency (EMA),; 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. Section of Medical Statistics, CEMSIIS Medical University of Vienna; Vienna Austria

7. Novartis, Modeling & Simulation, Pharma Development; Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1038/psp.2013.4/fullpdf

Reference12 articles.

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4. The effect of tacrine and lecithin in Alzheimer's disease. A population pharmacodynamic analysis of five clinical trials;Holford;Eur. J. Clin. Pharmacol.,1994

5. Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation;Chan;Pharm. Res.,2007

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