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PODCAST

Clinical Pharmacology Podcast with Nathan Teuscher

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.

science life sciences

All Episodes

00:26:05

How important is terminal rate constant? (Ep. 30)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/07/22

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 infinity, reviewed the methods for calculating the terminal rate constant value, and some important points about sample selection. Finally, I gave my reasons that we should ultimately stop talking about this and fretting over the method of calculation. Instead, let’s design better PK experiments with

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00:18:51

Parellelization in modeling (Ep. 29)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/07/08

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 in parallelization and also discussed different modeling computer systems you can use.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 Reserved

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00:27:40

Residual errors and submission packages (Ep. 28)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/06/24

Today I covered 2 different topics. First, I spoke about residual error models when modeling. I discussed additive, proportional, and power models. I also reviewed combined models and when they can be helpful. Then I spoke about modeling report submission packages. I explained what I put in those packages, how they are used, and some potential changes coming in the future.Links discussed in the show: Publication on model master file You can connect with me on LinkedIn and send me a message

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00:20:50

Simulations (Ep. 27)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/06/10

This episode discusses simulations. I group simulations into 4 categories: (1) average response, (2) population, (3) individual, and (4) clinical trial simulations. I discuss details of each of these types of simulations and the different variability terms included in each one. I strongly recommend that we implement more clinical trial simulations in our work. This will help us design and execute more successful clinical trials that take advantage of our existing knowledge about a drug. Enjoy the

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00:35:41

Different work environments (Ep. 26)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/05/27

Today’s show is about different work environments and not scientific topics. Throughout my career I have worked in many different types of companies, and I would like to share some observations with you from those experiences. I have held positions at startup companies or small biotechnology companies, large pharmaceutical companies, contract research laboratories, consulting firms, and working for myself as a consultant, and now as a software developer. Although my work has been focused on clinical

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00:16:53

Biosimilar products (Ep. 25)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/05/13

Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of interchangeability between the biosimilar and reference products.Links discussed in the show: FDA Guidance on Clinical Pharmacology Data to support Biosimilarity (May 2016) FDA Guidance on

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00:24:23

Choosing an absorption model (Ep. 24)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/04/22

Today’s show discussed approaches for modeling absorption profiles. I discussed the rationale behind modeling absorption and then described some common models. These included first-order absorption, zero-order absorption, transit compartments, distributed delay, Weibull, and zero/first order absorption. I also provided my recommendations on how to model absorption.Links discussed in the show: Distributed delay modeling in PK and PD Modeling biphasic formulation of methylphenidate You

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00:29:41

What is Aplos NCA? (Ep. 23)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/04/08

Today’s show was an overview of Aplos Analytics and the development story for Aplos NCA. Please consider participating in the Early Access Program. Use the link below to learn more about Aplos NCA.Links discussed in the show: Aplos Analytics website Aplos Analytics Contact Us Page 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 Reserved

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00:18:03

Big announcement and Hepatic impairment studies (Ep. 22)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/03/25

Today’s show is about hepatic impairment clinical studies. I cover the rationale behind evaluating hepatic impairment, common study designs, and key factors in the analysis and interpretation of the study results. I also share a huge announcement about Aplos NCA, a cloud-based solution for calculating NCA PK parameters. Use the link below to learn more about Aplos NCA.Links discussed in the show: FDA guidance EMA guideline Aplos Analytics website You can connect with me on LinkedIn and

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00:39:29

Project Optimus (Ep. 21)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/03/11

Today’s episode was about Project Optimus, the FDA initiative to improve dose selection and optimization for oncology products. Julie Bullock was a guest on this episode and shared her expertise as a former oncology clinical pharmacology reviewer at the FDA and as a current consultant in the pharmaceutical industry. Links discussed in the show: Project Optimus FDA List of FDA guidances and publications for Project Optimus May 2022 FDA-ASCO workshop: Getting the Dose Right: Optimizing Dose

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00:15:48

Tackling TMDD Models (Ep. 20)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/02/26

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 data and determine if a TMDD model is needed. I review the various modeling approaches along with my recommendations for specific TMDD models. I hope this information helps you understand how to recognize TMDD behaviors and the options for modeling that data.Links discussed in the show: A tutorial on target-mediated drug disposition (TMDD) models

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00:46:15

Communication for scientists (Ep. 19)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/02/12

Today’s episode is about communication for scientists. I believe that improvements in communication skills can have a greater impact on your career and work than technical skills. Michael Piperno, an expert in communication and leadership skills joins me to discuss communication challenges and solutions for clinical pharmacologists and pharmacometricians. Links discussed in the show: You can connect with Michael On his website On LinkedIn On his blog On his podcast Subscribe to

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00:13:11

Cell Therapy and Clinical Pharmacology (Ep. 18)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/01/22

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 pharmacology in this new area of research. Links discussed in the show: CAR T-cell Therapy Image 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 Reserved

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00:17:11

Allometry in Pediatrics and First in Human Studies...

Clinical Pharmacology Podcast with Nathan Teuscher ·

2024/01/08

Happy New Year! Today’s episode is all about allometric scaling in pharmacokinetic and pharmacodynamics. In particular, I’ll discuss how to use it for scaling from adults to pediatrics and for selection of first in human doses. Links discussed in the show: Boxenbaum manuscript FDA guidance on First in Human doses 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 Reserved

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00:30:13

Computer System Validation for Pharmacometrics (Ep. 16)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/12/25

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 pharmacometrics. I review my experience with validation in multiple companies over 20 years and discuss what auditors and FDA inspectors want to see. Links discussed in the show: Computer system validation guidance for medical devices Computer systems used in clinical trials Computer system assurance guidance for medical devices EMA

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00:26:10

QSP, PBPK, PKPD, PopPK … analysis abbreviation soup!...

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/12/11

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 either drug concentrations, or a response variable. But each method is developed in a different way and has different assumptions and limitations. 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 Reserved

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00:22:39

Handling BLQ samples (Ep. 13)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/11/27

In today’s episode I discuss BLQ handing for both non-compartmental and modeling analysis approaches. I discuss how BLQ samples are defined, methods for analyzing them, and situations when you should use different analysis approaches. Links discussed in the show: FDA guidance on bioanalytical method validation ICH M10 guidance on bioanalytical method validation Handling data below the limit of quantitation in mixed effects models Ways to fit a PK model with some data below the

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00:19:56

Clinical Drug Interaction Studies (Ep. 14)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/11/27

In today’s episode I covered the different types of drug interactions, followed by features of clinical drug evaluation studies recommended in the guidance. Then I will review recommendations for both stand-alone clinical drug interaction studies, as well as nested drug interaction studies. I’ll finish with recommended approaches for interpreting drug interaction study results and expressing that information in drug labeling. Links discussed in the show: Prevalence and factors associated with

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00:14:22

PK in patients with impaired renal function (Ep. 12)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/10/23

In today’s episode I discuss the evaluation of pharmacokinetics in patients with impaired renal function. I include information from both the US FDA and EMA guidance documents linked below. I discuss the determination of when a dedicated renal impairment study is needed, characteristics of the study design and how to analyze and interpret the results. Links discussed in the show: • FDA guidance on PK in patients with impaired renal function • EMA guidance on Evaluation of PK in patients with

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00:31:13

Model diagnostics and selection (Ep. 11)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/10/09

This episode is a discussion on model evaluation and selection. I discussed diagnostic plots using predictions and residuals. I covered approaches for model selection and factors to consider. The focus of this episode is on models that predict continuous endpoints like drug concentration, biomarkers, or other continuous endpoints. Several figures are mentioned in the podcast and links to those images can be found below. Links discussed in the show: Figure 1: Observed vs Predicted for

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