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    Life Sciences

    Clinical Pharmacology Podcast with Nathan Teuscher

    I discuss clinical pharmacology and pharmacometrics topics from the perspective of drug development scientists. I share my expertise and knowledge about designing and conducting clinical pharmacology studies and discuss how to analyze the data using the most effective approaches. I draw from my experience of over 20 years working in drug development organizations and consultancies.

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    Copyright: © Nathan Teuscher

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    Latest Episodes:
    Inter-occasion variability and shrinkage in PK modeling (Ep. 61) Oct 26, 2026
    Show notes

    Today’s episode is about inter-occasion variability and η-shrinkage. Episodes 11, 36, 44, and 45 covered diagnostics, covariate search, estimation methods, and base-model selection. None of them treated occasion variability or shrinkage in population PK modeling. So in today's episode I'll explain what these terms mean and how they may impact your work.


    Links mentioned in the episode:

    • Paper by Karlsson and Sheiner
    • Paper by Savic and Karlsson
    • FDA guidance on Population PK


    Copyright Teuscher Solutions LLC. All rights reserved.



    Exposure-Response modeling Oct 02, 2026
    Show notes

    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
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC


    All Rights Reserved



    Renal and Hepatic Impairment (Ep. 59) Aug 24, 2026
    Show notes

    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:

    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter

    Copyright Teuscher Solutions LLC

    All Rights Reserved



    Beyond Small Molecules—Allometric Scaling for Biologics and Engineered mAbs (Ep. 58) Jul 27, 2026
    Show notes

    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
    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter


    Copyright Teuscher Solutions LLC

    All Rights Reserved



    Bioequivalence Testing: The Stats Behind Generic Drug Approvals (Ep. 57) May 25, 2026
    Show notes

    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


    Examining Volume of Distribution (Ep. 56) Apr 20, 2026
    Show notes

    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


    Talking about data science with Mike Stackhouse (Ep. 55) Mar 16, 2026
    Show notes

    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


    Using Accelerator Mass Spectrometry in Clinical Pharmacology Feb 16, 2026
    Show notes

    This episode is an interview with Dr. Wouter Vaes, the Chief Science Officer of Peregrion. We discuss how accelerator mass spectrometry is being used in early clinical development for drug metabolism and pharmacokinetics. We discuss using this technology to support development of oncology agents, determining absolute bioavailability without IV toxicology work, and more.


    Links discussed in the show:

    • You can contact Wouter by email: wouter.vaes@peregrion.com
    • Connect with Peregrion on LinkedIn or their website
    • Symposium on microtracer studies
    • FDA guidance on safety testing of drug metabolites
    • White paper on human ADME data
    • 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


    Using AI tools for regulatory intelligence (Ep. 53) Jan 19, 2026
    Show notes

    This episode is an interview with Aruna Dhontabhaktuni, Founder and CEO of RegKey, a regulatory intelligence platform that uses AI. The discussion touches on how companies can leverage large language model AI tools to accelerate regulatory strategy work.


    Links discussed in the show:

    • You can contact Aruna by email: arunad@regkey.ai
    • Visit the RegKey website
    • Connect with Aruna on LinkedIn
    • 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


    When to use model-informed drug development (Ep. 52) Dec 22, 2025
    Show notes

    This episode is a collection of my thoughts on model-informed drug development and where different modeling modalities fit into the development schedule. These are just my opinions and each development program is different.

    Links discussed in the show:

    • You can connect with me on LinkedIn and send me a message
    • Send me a message
    • Sign up for my newsletter

    Copyright Teuscher Solutions LLC

    All Rights Reserved



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