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Clinical Pharmacology Podcast with Nathan Teuscher: Daily Summaries Delivered
by 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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- 1 weeks ago24 min
Bioequivalence Testing: The Stats Behind Generic Drug Approvals (Ep. 57)
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 Links discussed in the show:FDA Draft Guidance: Statistical Approaches to Establishing Bioequivalence (Dec 2022) – Excellent detail on methods, models, and SAS examples.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 LLCAll Rights Reserved
- Apr 20, 202619 min
Examining Volume of Distribution (Ep. 56)
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 LLCAll Rights Reserved
- Mar 16, 202645 min
Talking about data science with Mike Stackhouse (Ep. 55)
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 websiteYou can connect with Nathan on LinkedIn and send me a messageSend Nathan a messageSign up for Nathan’s newsletterCopyright Teuscher Solutions LLCAll Rights Reserved
- Feb 16, 202638 min
Using Accelerator Mass Spectrometry in Clinical Pharmacology
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 websiteSymposium on microtracer studies FDA guidance on safety testing of drug metabolitesWhite 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 LLCAll Rights Reserved
- Jan 19, 202621 min
Using AI tools for regulatory intelligence (Ep. 53)
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.aiVisit 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
- Dec 22, 202528 min
When to use model-informed drug development (Ep. 52)
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 LLCAll Rights Reserved
- Nov 24, 202544 min
QSP Modeling with Ahmed Elmokadem (Ep. 51)
In this episode I chat with Ahmed Elmokadem about QSP modeling. Ahmed, from Metrum Research Group, is an expert consultant in QSP modeling and how it can be used to provide a framework to connect mechanistic understanding with clinical pharmacology and decision-making.Links discussed in the show:Connect with Ahmed on LinkedIn on on his websiteAhmed’s book: Numbers that Dazzled the World You can connect with me on LinkedIn and send me a messageSend me a messageSign up for my newsletter
- Oct 27, 202518 min
CDISC datasets and ACoP 2025 (Ep. 50)
In this episode I discuss dataset-JSON, a new proposed data standard for CDISC files and explain some of the CDISC files I use in my clinical pharmacology work. I end with some brief thoughts about the ACoP 2025 meeting in Denver in October 2025.Links discussed in the show:CDISC dataset-JSON CDISC files I use You can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletter Copyright Teuscher Solutions LLCAll Rights Reserved
About 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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