Clinical Pharmacology Podcast with Nathan Teuscher

Latest Episodes:

Sample size calculations (Ep. 41) Jan 31, 2025

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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 Me information)
Example R code (Change the filetype to .R after downloading)
Statistical Power
Statistical approaches to establishing Bioequivalence from FDA
Calculation of CV
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Collaboration with BioTalk Unzipped (Ep. 40) Dec 30, 2024

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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 the upcoming show!

Links discussed in the show:

BioTalk Unzipped main page
BioTalk Unzipped YouTube channel
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Toxicokinetics (Ep. 39) Dec 09, 2024

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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:

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Steady State (Ep. 38) Nov 25, 2024

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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:

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Dose Proportionality (Ep. 37) Nov 11, 2024

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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
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Covariate Search Methods (Ep. 36) Oct 28, 2024

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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
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Stimulatory Indirect Response PK-PD Models (Ep. 35) Oct 14, 2024

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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
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Inhibitory Indirect Response PK-PD Models (Ep. 34) Sep 23, 2024

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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
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Effect compartment PK-PD models (Ep. 33) Sep 09, 2024

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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
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Direct effect PKPD models (Ep. 32) Aug 26, 2024

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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 to code the model in NONMEM. This is the first of 4 episodes on different PK-PD models.

Links discussed in the show: