Clinical Pharmacology Podcast with Nathan Teuscher

Exposure-Response modeling

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

Renal and Hepatic Impairment (Ep. 59)

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 impa

Beyond Small Molecules—Allometric Scaling for Biologics and Engineered mAbs (Ep. 58)

Today’s episode is about allometric scaling with therapeutic antibodies. I discuss differences from small molecules, how to handle antibodies with engineered Fc regions (

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 d

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, e

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,

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 de

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 companie

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 m

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 provi

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 wit

Statistics in Pharmacokinetics (Ep. 49)

In this episode I discuss review statistics that are commonly used in pharmacokinetics and pharmacometrics work. I reviewed the basic theory of the normal distribution an

Clinical Trial Simulations (Ep. 48)

In this episode I discuss clinical trial simulations. I review concepts of trial simulation including different variability terms and when to use them. I also share my th

Using R Shiny for Clinical Pharmacology (Ep. 47)

In this episode I discuss R Shiny and how it can be used for building clinical pharmacology tools. I provide an overview of the technology, suggest a few example use case

What is useful about noncompartmental analysis? (Ep. 46)

In this episode I discuss noncompartmental analysis. I categorize PK parameters calculated by NCA methods as either Important, Useful, or Questionable. I also share my th

How to select a base PK model (Ep. 45)

In this episode I review the process I follow for fitting a base pharmacokinetic (PK) model. I talk from the perspective of an individual PK model, but include some diffe

Different estimation methods used in modeling (Ep. 44)

In this episode I discuss different algorithms used for pharmacometrics modeling. I describe difference between maximum likelihood and expectation maximization methods. I

What is consulting life like? (Ep. 43)

In this episode I discuss my experience as an independent consultant in the clinical pharmacology and pharmacometrics space. I talk about how I got from high school to be

Population PK modeling with nlmixr (Ep. 42)

In this episode I discuss using nlmixr for population PK modeling in R. I give an overview of the software package, describe the installation process, and walk through a

Sample size calculations (Ep. 41)

In this episode I discuss power calculations using the R package PowerTOST. I gave an introduction to power calculations and the statistical premise. I reviewed bioequiva