Bioequivalence Testing: The Stats Behind Generic Drug Approvals (Ep. 57)

<p>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. </p><p><br></p><p>Links discussed in the show:</p><p><br></p><ul><li><a href="https://www.fda.gov/media/163638/download" target="_blank" rel="noopener noreferer">FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (Dec 2022)</a> – Excellent detail on methods, models, and SAS examples. </li><li><a href="https://www.fda.gov/media/87219/download" target="_blank" rel="noopener noreferer">FDA Guidance: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.</a> </li><li>Article: <a href="https://pubmed.ncbi.nlm.nih.gov/26132680/" target="_blank" rel="noopener noreferer">“Bioequivalence of generic drugs: a simple explanation for clinicians” (Andrade, 2015)</a> – Great for the 80-125% intuition. </li><li><a href="https://teuschersolutions.com/wp-content/uploads/2026/05/BE-example_r.txt" target="_blank" rel="noopener noreferer">R-script with example BE analysis</a> (Be sure to copy this text into a file and name it &quot;BE-example.R&quot; then you can run it on your local R instance.</li><li>You can connect with <a href="https://go.teuschersolutions.com/linkedin" target="_blank" rel="noopener noreferer">Nathan on LinkedIn</a> and send me a message </li><li><a href="https://go.teuschersolutions.com/contact" target="_blank" rel="noopener noreferer">Send Nathan a message</a> </li><li><a href="https://go.teuschersolutions.com/newsletter" target="_blank" rel="noopener noreferer">Sign up for Nathan’s newsletter</a> </li></ul><p><br></p><p>Copyright Teuscher Solutions LLC</p><p>All Rights Reserved</p>