Clinical Pharmacology Podcast with Nathan Teuscher

Today’s episode is about exposure response modeling. What is ER analysis? When is it used? How do you do it? And what tools can be used for ER modeling?
Links discussed in the show:
ICH M15 Guideline
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Today’s episode is a discussion of renal and hepatic impairment. I review the biology of the kidney and liver and how we analyze pharmacokinetic data to assess their impact on drug exposure.

Links discussed in the show:
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Today’s episode is about allometric scaling with therapeutic antibodies. I discuss differences from small molecules, how to handle antibodies with engineered Fc regions (e.g. YTE or LS), and using allometry to extrapolate from adults to pediatrics for these antibodies.

Links discussed in the show:
Haray and Tachibana’s article on allometric exponents for monoclonal antibodies
Exponents for standard antibodies: CL = 0.8, Q = 0.75, Vc = 1/.0, Vp = 0.95
Exponents for modified antibodies: CL = 0.55, Q = 6, Vc = 0.95, Vp = 0.95
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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FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (Dec 2022) – Excellent detail on methods, models, and SAS examples.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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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
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