Episode Details

In this episode I discuss bioequivalence testing and how it was developed to support generic drug approvals, but is now a mainstream tool for all of drug development. I discuss the basics of what bioequivalence means, how the studies are designed, and then how to perform the statistical analysis. I end with some examples of how this can be used for both generic drug and innovator drugs to support labeling.

Links discussed in the show:

• FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (Dec 2022) – Excellent detail on methods, models, and SAS examples.
• FDA Guidance: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.
• Article: “Bioequivalence of generic drugs: a simple explanation for clinicians” (Andrade, 2015) – Great for the 80-125% intuition.
• R-script with example BE analysis (Be sure to copy this text into a file and name it "BE-example.R" then you can run it on your local R instance.
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