I want to see if any members have 1st hand experience in evaluating Reference scaled average bioequivalence in Three-period fully replicated design (latest guidance provides this avenue). Anyone share their experiences or SAS/R-code for establishing Bioequivalence under this new option. Posting this to generate some discussion around this subject.
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Prasad Tata M. Pharm, Ph.D., FCP
Sr. Director-PK/BE
American Regent, Inc.
Princeton NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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