Course: Biostatistics for Medical Product Regulation

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Biostatistics for Medical Product Regulation



Mary Foulkes and Simon Day

Originally Offered :

Fall 2008

Offered By:

Department of Biostatistics

Course Number:



Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.