Clinical Pharmacology Podcast with Nathan Teuscher

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...

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 c...

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...

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...

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 con...

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 R...

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 website Ahmed’s book: Numbers that Dazzled the World You can...

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...

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 and then discussed various individual statistics that we use in PK work. I concluded with some examples of which statistics I use in my work. Links discussed in the show: Link to message about harmonic mean You can connect with me o...

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 thoughts on 3 different applications used in clinical trial simulation. Links discussed in the show: Trial Simulator Software page Simulx Software page You can connect with me on LinkedIn and send me a message Send me a message Sign...

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 cases, and then walk through a specific practical example of predicting AUC and Cmax for future doses from observed data. I end with a discussion of the benefits and challenges of using R Shiny for clinical pharmacology tools. Links d...

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 thoughts on how to report PK parameters calculated using NCA methods in nonclinical and clinical reports. I want to hear your thoughts about this episode. Do you agree or disagree with my categorization of PK parameters? Why? Use th...

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 differences associated with population PK models. I go over exploratory data analysis, getting initial estimates, and how to choose between different base models. Links discussed in the show: AIC and BIC You can connect with me on Link...

In this episode I discuss different algorithms used for pharmacometrics modeling. I describe difference between maximum likelihood and expectation maximization methods. I review the FO and FOCEI maximum likelihood algorithms. I then review SAEM, IMP, and QRPEM expectation maximization algorithms that are available. I conclude with an brief explanation of the difference between parameter estimation...

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 become a consultant. I touched on the many different activities I do as an independent consultant. I shared a bit about how I handle compensation with clients and how I pay myself. And I ended with some brief comments about getting...

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 simple example. Overall, nlmixr is a nice package that can be used for most modeling activities you encounter. It eliminates the need for a license since it is open-source. There are some challenges associated with using R for mod...

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 bioequivalence study designs that are commonly used for generic drug development, food effect evaluation, and drug-drug interaction studies. Links discussed in the show: PowerTOST R package PowerTOST instructions (scroll down to the Read M...

In this episode I share a couple short clips from my conversation with Chad Briscoe and Greg Austin from BioTalk Unzipped ( www.biotalkunzipped.com ). We chat about a variety of topics including artificial intelligence and challenges with cell therapy development. You can hear the entire conversation on the BioTalk Unizipped podcast or YouTube channel in January. For now, enjoy these clips from th...

In this episode I discuss toxicokinetic analysis. This is the analysis of exposure data to support animal toxicology studies. I review the purpose of toxicology studies and how exposure metrics are used. Then I discuss different blood sampling schemes, and how to calculate exposure parameters for both full profiles and mean profiles. Links discussed in the show: You can connect with me on LinkedIn...

This episode is a discussion of steady state pharmacokinetics. Steady state occurs when the amount of drug input is equivalent to the amount of drug elimination in a dosing interval. I discuss some key PK parameters at steady state and how to use them. I also discuss different methods of confirming that you have reached steady state. Links discussed in the show: You can connect with me on LinkedIn...

In this episode I talk about dose proportionality, which is a surrogate for determining if we have linear clearance across a range of dose levels. I discuss 3 different methods that people use to determine dose proportionality along with a recommendation to use the power model method. Links discussed in the show: Power model method You can connect with me on ⁠LinkedIn and send me a message⁠⁠ Send...

This episode is a discussion of covariate search methods. I give definitions of covariates and predictors, and then I describe 3 different covariate search methods. For each method I describe the pros and cons associated with each one, including bias and time limitations. Links discussed in the show: Evaluation of the Boruta method for covariate selection You can connect with me on LinkedIn and se...

In this episode I describe stimulatory indirect response PK-PD models. I describe how they work, how to set up the dataset for NONMEM, and how to code the model in NONMEM. This is the last of 4 episodes on different PK-PD models. Links discussed in the show: Indirect response PK-PD model equations Example NONMEM code for stimulatory indirect response PK-PD model You can connect with me on LinkedIn...

In this episode I describe inhibitory indirect response PK-PD models. I describe how they work, how to set up the dataset for NONMEM, and how to code the model in NONMEM. This is the third of 4 episodes on different PK-PD models. Links discussed in the show: Indirect response PK-PD model equations Example NONMEM code for inhibitory indirect response PK-PD model You can connect with me on LinkedIn...

In this episode I describe effect compartment PK-PD models. I describe how they work, a method of creating exploratory plots, how to set up the dataset for NONMEM, and how to code the model in NONMEM. This is the 2nd of 4 episodes on different PK-PD models. Links discussed in the show: Example NONMEM code for effect compartment model You can connect with me on LinkedIn and send me a message Send m...