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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 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…

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42: 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 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…

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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 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…

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40: Collaboration with BioTalk Unzipped (Ep. 40)

In this episode I share a couple short clips from my conversation with Chad Briscoe and Greg Austin from BioTalk Unzipped (http://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…

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39: Toxicokinetics (Ep. 39)

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…

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38: Steady State (Ep. 38)

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…

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37: Dose Proportionality (Ep. 37)

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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36: Covariate Search Methods (Ep. 36)

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…

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35: Stimulatory Indirect Response PK-PD Models (Ep. 35)

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…

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34: Inhibitory Indirect Response PK-PD Models (Ep. 34)

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…

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