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MRA 605 Analytical Methods for Regulatory Affairs

Lead Faculty: Dr. Patric M. Schiltz

Course Description

This course will give the student the fundamental knowledge of statistical concepts and analytical methods as applied to biomedical science and clinical trials.  It will emphasize basic concepts of methodology and experimental design, quantitative analysis of data, and statistical significance.  A case study approach will be used to cover the basic designs of clinical trials with emphasis on appropriate methodoliges, endpoint variables, control groups, blinded studies, eligibility criteria, and placebo control.  The course will cover statistical analysis including probabilities and variables.  Students will be required to design and implement a full protocol for a fictitious drug or medical device elucidating the data for approval.

Course Information