Comparisons of Analysis Methods for Proof-of-Concept Trials

Author:

Karlsson KE1,Vong C1,Bergstrand M1,Jonsson EN12,Karlsson MO1

Affiliation:

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

2. Exprimo NV; Mechelen Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Reference50 articles.

1. FDA Challenge and Opportunity on the Critical Path to New Medical Products http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm113411.pdf 2004

2. The future of drug development: advancing clinical trial design;Orloff;Nat. Rev. Drug Discov.,2009

3. Price Waterhouse Coopers Pharma 2020 Series http://www.pwc.com/pharma 2007 2011

4. ASCPT Task Force for advancing pharmacometrics and integration into drug development;Goldberger;Clin. Pharmacol. Ther.,2010

5. Pharmacometrics: a multidisciplinary field to facilitate critical thinking in drug development and translational research settings;Barrett;J. Clin. Pharmacol.,2008

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