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BMS 513 Biostatistics in Regulatory Applications

Prerequisite: Open to students with a declared concentration in regulatory compliance. (First semester—even years/3 credits))  

This course will provide the student with a broad understanding of the application of biostatistics in the regulatory context. Course topics will focus on the basic study design, target population, comparision groups and endpoints for animal studies through clinical trials phase I-IV. Specific emphasis will be placed on addressing issues within the US regulatory environment.