Clinical Pharmacology Podcast with Nathan Teuscher
Episodes
When to use model-informed drug development (Ep. 52)
22 Dec 2025
Contributed by Lukas
This episode is a collection of my thoughts on model-informed drug development and where different modeling modalities fit into the development schedu...
QSP Modeling with Ahmed Elmokadem (Ep. 51)
24 Nov 2025
Contributed by Lukas
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 ...
CDISC datasets and ACoP 2025 (Ep. 50)
27 Oct 2025
Contributed by Lukas
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 pharmaco...
Statistics in Pharmacokinetics (Ep. 49)
22 Sep 2025
Contributed by Lukas
In this episode I discuss review statistics that are commonly used in pharmacokinetics and pharmacometrics work. I reviewed the basic theory of the no...
Clinical Trial Simulations (Ep. 48)
25 Aug 2025
Contributed by Lukas
In this episode I discuss clinical trial simulations. I review concepts of trial simulation including different variability terms and when to use them...
Using R Shiny for Clinical Pharmacology (Ep. 47)
28 Jul 2025
Contributed by Lukas
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 ...
What is useful about noncompartmental analysis? (Ep. 46)
23 Jun 2025
Contributed by Lukas
In this episode I discuss noncompartmental analysis. I categorize PK parameters calculated by NCA methods as either Important, Useful, or Questionable...
How to select a base PK model (Ep. 45)
27 May 2025
Contributed by Lukas
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, bu...
Different estimation methods used in modeling (Ep. 44)
21 Apr 2025
Contributed by Lukas
In this episode I discuss different algorithms used for pharmacometrics modeling. I describe difference between maximum likelihood and expectation max...
What is consulting life like? (Ep. 43)
24 Mar 2025
Contributed by Lukas
In this episode I discuss my experience as an independent consultant in the clinical pharmacology and pharmacometrics space. I talk about how I got fr...
Population PK modeling with nlmixr (Ep. 42)
24 Feb 2025
Contributed by Lukas
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,...
Sample size calculations (Ep. 41)
31 Jan 2025
Contributed by Lukas
In this episode I discuss power calculations using the R package PowerTOST. I gave an introduction to power calculations and the statistical premise. ...
Collaboration with BioTalk Unzipped (Ep. 40)
30 Dec 2024
Contributed by Lukas
In this episode I share a couple short clips from my conversation with Chad Briscoe and Greg Austin from BioTalk Unzipped (www.biotalkunzipped.com). W...
Toxicokinetics (Ep. 39)
09 Dec 2024
Contributed by Lukas
In this episode I discuss toxicokinetic analysis. This is the analysis of exposure data to support animal toxicology studies. I review the purpose of ...
Steady State (Ep. 38)
25 Nov 2024
Contributed by Lukas
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 e...
Dose Proportionality (Ep. 37)
11 Nov 2024
Contributed by Lukas
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 d...
Covariate Search Methods (Ep. 36)
28 Oct 2024
Contributed by Lukas
This episode is a discussion of covariate search methods. I give definitions of covariates and predictors, and then I describe 3 different covariate s...
Stimulatory Indirect Response PK-PD Models (Ep. 35)
14 Oct 2024
Contributed by Lukas
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...
Inhibitory Indirect Response PK-PD Models (Ep. 34)
23 Sep 2024
Contributed by Lukas
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 ...
Effect compartment PK-PD models (Ep. 33)
09 Sep 2024
Contributed by Lukas
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 datase...
Direct effect PKPD models (Ep. 32)
26 Aug 2024
Contributed by Lukas
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 mode...
What should you use to present PK results? (Ep. 31)
12 Aug 2024
Contributed by Lukas
In this episode I discuss different methods of presenting pharmacokinetic and pharmacometrics results. I spoke about using PowerPoint and R Markdown d...
How important is terminal rate constant? (Ep. 30)
22 Jul 2024
Contributed by Lukas
This episode covers the terminal elimination rate constant calculated using non-compartmental analysis techniques. I reviewed how the rate constant is...
Parellelization in modeling (Ep. 29)
08 Jul 2024
Contributed by Lukas
This episode covered parallelization in modeling analyses. I spoke about across model parallelization and within model parallelization. I recommended ...
Residual errors and submission packages (Ep. 28)
24 Jun 2024
Contributed by Lukas
Today I covered 2 different topics. First, I spoke about residual error models when modeling. I discussed additive, proportional, and power models. I ...
Simulations (Ep. 27)
10 Jun 2024
Contributed by Lukas
This episode discusses simulations. I group simulations into 4 categories: (1) average response, (2) population, (3) individual, and (4) clinical tria...
Different work environments (Ep. 26)
27 May 2024
Contributed by Lukas
Today’s show is about different work environments and not scientific topics. Throughout my career I have worked in many different types of companies...
Biosimilar products (Ep. 25)
13 May 2024
Contributed by Lukas
Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary co...
Choosing an absorption model (Ep. 24)
22 Apr 2024
Contributed by Lukas
Today’s show discussed approaches for modeling absorption profiles. I discussed the rationale behind modeling absorption and then described some com...
What is Aplos NCA? (Ep. 23)
08 Apr 2024
Contributed by Lukas
Today’s show was an overview of Aplos Analytics and the development story for Aplos NCA. Please consider participating in the Early Access Program. ...
Big announcement and Hepatic impairment studies (Ep. 22)
25 Mar 2024
Contributed by Lukas
Today’s show is about hepatic impairment clinical studies. I cover the rationale behind evaluating hepatic impairment, common study designs, and key...
Project Optimus (Ep. 21)
11 Mar 2024
Contributed by Lukas
Today’s episode was about Project Optimus, the FDA initiative to improve dose selection and optimization for oncology products. Julie Bullock was a ...
Tackling TMDD Models (Ep. 20)
26 Feb 2024
Contributed by Lukas
Today’s show is about TMDD or target-mediated drug disposition models. I review the scientific and physiologic basis for TMDD models, how to review ...
Communication for scientists (Ep. 19)
12 Feb 2024
Contributed by Lukas
Today’s episode is about communication for scientists. I believe that improvements in communication skills can have a greater impact on your career ...
Cell Therapy and Clinical Pharmacology (Ep. 18)
22 Jan 2024
Contributed by Lukas
Today’s episode is about cell therapies, including CAR T-cell theraphy for cancer. I give an overview of cell therapy and the challenges of clinical...
Allometry in Pediatrics and First in Human Studies (Ep. 17)
08 Jan 2024
Contributed by Lukas
Happy New Year! Today’s episode is all about allometric scaling in pharmacokinetic and pharmacodynamics. In particular, I’ll discuss how to use it...
Computer System Validation for Pharmacometrics (Ep. 16)
25 Dec 2023
Contributed by Lukas
This is the last podcast for 2023. Thank you for listening throughout the year! In today’s episode I talk about computer system validation for pharm...
QSP, PBPK, PKPD, PopPK … analysis abbreviation soup! (Ep. 15)
11 Dec 2023
Contributed by Lukas
In today’s episode I cover 4 different modeling approaches: QSP, PBPK, PopPK, and PKPD. All of these are methods for analyzing data to predict eithe...
Handling BLQ samples (Ep. 13)
27 Nov 2023
Contributed by Lukas
In today’s episode I discuss BLQ handing for both non-compartmental and modeling analysis approaches. I discuss how BLQ samples are defined, methods...
Clinical Drug Interaction Studies (Ep. 14)
27 Nov 2023
Contributed by Lukas
In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the g...
PK in patients with impaired renal function (Ep. 12)
23 Oct 2023
Contributed by Lukas
In today’s episode I discuss the evaluation of pharmacokinetics in patients with impaired renal function. I include information from both the US FDA...
Model diagnostics and selection (Ep. 11)
09 Oct 2023
Contributed by Lukas
This episode is a discussion on model evaluation and selection. I discussed diagnostic plots using predictions and residuals. I covered approaches for...
Exposure-Response FDA Guidance (Ep. 10)
25 Sep 2023
Contributed by Lukas
This episode is a discussion of the FDA guidance “Exposure-Response Relationships”. The relationship between drug exposure and response is critica...
Finding a job in Clinical Pharmacology (Ep. 9)
11 Sep 2023
Contributed by Lukas
This episode I talk about finding a job in Clinical Pharmacology or Pharmacometrics. I share a few thoughts from my experience followed by an intervie...
QT Prolongation Guidance ICH E14 (Ep. 8)
28 Aug 2023
Contributed by Lukas
This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential...
Pediatric Extrapolation (Ep. 7)
14 Aug 2023
Contributed by Lukas
Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Kushal and Parmesh. In this episode, I discuss ...
Bioequivalence Guidances from FDA and EMA (Ep. 6)
24 Jul 2023
Contributed by Lukas
Thank you to everyone who sent me feedback on this podcast. This episode is based on a suggestion from Drew. In this episode, I discuss bioequivalence...
Nuances of NCA (Ep. 5)
10 Jul 2023
Contributed by Lukas
In this episode, I discuss some nuances of non-compartmental analysis or NCA. I am going to focus on three separate parameters: Cmax, AUC, and the ter...
Population PK FDA guidance (Ep. 4)
03 Jul 2023
Contributed by Lukas
In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission re...
Comparing NCA and PK models (Ep. 3)
03 Jul 2023
Contributed by Lukas
In this episode, I discuss two data analysis techniques: (1) non-compartmental analysis or NCA, and (2) PK modeling. I discuss the basic premise of ea...
Food Effect FDA Guidance (Ep 2)
03 Jul 2023
Contributed by Lukas
In this episode, I discuss the 2022 FDA guidance on food effect studies. I discuss the timing of these studies in your development programs, various a...
Podcast about clinical pharmacology (Ep 1)
03 Jul 2023
Contributed by Lukas
In my inaugural episode, I introduce myself, describe the type of clinical pharmacology and pharmacometrics content I will share, let you know how to ...