Modeling and Simulation to Optimize the Design and Analysis of Confirmatory Trials, Characterize Risk–Benefit, and Support Label Claims
نویسندگان
چکیده
1Pfizer, Pharmacometrics, Global Clinical, Pharmacology, Sandwich, UK; 2European Medicines Agency (EMA), London, UK; 3Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK; 4Swedish Medical Products Agency (MPA), Uppsala, Sweden; 5Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden; 6Novartis, Modeling & Simulation, Pharma Development, Basel, Switzerland; 7Current address: Section of Medical Statistics, CEMSIIS Medical University of Vienna, Vienna, Austria. Correspondence: SF Marshall ([email protected]) Received 2 November 2012; accepted 14 January 2013; advance online publication 27 February 2013. doi:10.1038/psp.2013.4 M&S BEING CONDUCTED TO SUPPORT THE DESIGN OF CONFIRMATORY TRIALS
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