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• FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (Dec 2022) – Excellent detail on methods, models, and SAS examples.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.
• You can connect with Nathan on LinkedIn and send me a message
• Send Nathan a message
• Sign up for Nathan’s newsletter

Copyright Teuscher Solutions LLC

All Rights Reserved

In this episode we’re going to define Volume of Distribution, look at the different types of Volume of Distribution parameters, talk about how we actually calculate it, examine what drives its value, and—most importantly—discuss why it matters for the decisions we make every day in drug development.

Links discussed in the show:

• Volume of Distribution
• Volume of Distribution in Drug Design
• You can connect with Nathan on LinkedIn and send me a message
• Send Nathan a message
• Sign up for Nathan’s newsletter

Copyright Teuscher Solutions LLC

All Rights Reserved

This episode is an interview with Michael Stackhouse, the Chief Innovation Officer at Atorus Research. We discussed a variety of topics such as modern data science tools, why regulatory agencies want to get rid of SAS transport files in favor of Dataset JSON file formats, and how AI is being used in data programming and data science.

Links discussed in the show:

• Connect with Mike on LinkedIn
• Learn more about Atorus Research on their website
• You can connect with Nathan on ⁠LinkedIn and send me a message⁠⁠
• Send Nathan a message⁠⁠
• Sign up for Nathan’s newsletter⁠

Copyright Teuscher Solutions LLC

All Rights Reserved