An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review
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Abstract:
This paper provides a detailed example of how one should write the statistical section of a bioequivalence study protocol for FDA review. Three forms of bioequivalence are covered: average bioequivalence (ABE), population bioequivalence (PBE) and individual bioequivalence (IBE). The method of analysis is based on Jones and Kenward (2003) and a modification of their SAS Macro is provided.
Subject Area:
General Biostatistics
Suggested Citation:
William F. McCarthy, "An Example of How to Write the Statistical Section of a Bioequivalence Study Protocol for FDA Review" (July 2007). COBRA Preprint Series. Article 30.
http://biostats.bepress.com/cobra/ps/art30