Om 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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Using AI tools for regulatory intelligence (Ep. 53) (00:21:21)
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 ...
When to use model-informed drug development (Ep. 52) (00:28:16)
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 developmen...
QSP Modeling with Ahmed Elmokadem (Ep. 51) (00:44:37)
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 mech...
CDISC datasets and ACoP 2025 (Ep. 50) (00:18:46)
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 th...
Statistics in Pharmacokinetics (Ep. 49) (00:25:13)
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 indiv...
Clinical Trial Simulations (Ep. 48) (00:21:30)
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 applicat...
Using R Shiny for Clinical Pharmacology (Ep. 47) (00:19:37)
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 spe...
What is useful about noncompartmental analysis? (Ep. 46) (00:27:10)
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 par...
How to select a base PK model (Ep. 45) (00:27:40)
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 populat...
Different estimation methods used in modeling (Ep. 44) (00:25:37)
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 maxim...
What is consulting life like? (Ep. 43) (00:30:05)
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 o...
Population PK modeling with nlmixr (Ep. 42) (00:25:55)
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, nlmix...
Sample size calculations (Ep. 41) (00:34:39)
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 c...
Collaboration with BioTalk Unzipped (Ep. 40) (00:13:53)
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 artific...
Toxicokinetics (Ep. 39) (00:19:03)
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 us...
Steady State (Ep. 38) (00:16:27)
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 ke...
Dose Proportionality (Ep. 37) (00:16:58)
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 dete...
Covariate Search Methods (Ep. 36) (00:27:22)
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...
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 episod...
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 episod...
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....
Direct effect PKPD models (Ep. 32) (00:31:34)
In this episode I describe direct effect PK-PD models. I describe how they work, a method of creating exploratory plots to identify direct effect models, how to set up the dataset for NONMEM, and how ...
What should you use to present PK results? (Ep. 31) (00:31:24)
In this episode I discuss different methods of presenting pharmacokinetic and pharmacometrics results. I spoke about using PowerPoint and R Markdown derived HTML files. While I prefer HTML files in ne...
How important is terminal rate constant? (Ep. 30) (00:26:05)
This episode covers the terminal elimination rate constant calculated using non-compartmental analysis techniques. I reviewed how the rate constant is used to estimate half-life and extrapolate AUC to...
Parellelization in modeling (Ep. 29) (00:18:51)
This episode covered parallelization in modeling analyses. I spoke about across model parallelization and within model parallelization. I recommended some approaches for choosing how many cores to use...
