Nathan Teuscher

Clinical Pharmacology Podcast with Nathan Teuscher

Science EN ↓ 57 episodes

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.

Author

Nathan Teuscher

Episodes

Pediatric Extrapolation (Ep. 7) 14.08.2023 24:51

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 a general clinical pharmacology pediatric extrapolation plan. I describe the basics of the plan that is commonly proposed to regulatory bodies. I discuss specific technical approaches for extrapolation of adult pharmacokinetic data to pediatric patie...

Bioequivalence Guidances from FDA and EMA (Ep. 6) 24.07.2023 30:14

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 studies and generic drug development. I will refer to guidance documents from both the European Medicines Agency or EMA and the US Food and Drug Administration or FDA. First, I will start with a discussion of the definition of bioequivalence or BE....

Nuances of NCA (Ep. 5) 10.07.2023 20:26

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 terminal elimination rate constant. These three are the most commonly used parameters to describe drug exposure. I’ll discuss the basic methodology for each and then discuss challenges that may arise when you are performing an analysis. Links discussed...

Population PK FDA guidance (Ep. 4) 03.07.2023 36:06

In this episode, I discuss the 2022 FDA Guidance on Population PK analysis. This includes a discussion of the applications, methods, and submission requirements for population PK models. Links discussed in the show: • FDA Population PK Guidance • 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 Res...

Comparing NCA and PK models (Ep. 3) 03.07.2023 17:44

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 each method and similarities and differences between them. Links discussed in the show: Publication about NCA by Johan Gabrielsson and Dan Weiner Publication about PK modeling by Hartmut Derendorf et. al. Play Angry Birds as a fun diversion today Here’...

Food Effect FDA Guidance (Ep 2) 03.07.2023 17:55

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 aspects of study design, and some unique exceptions to the standard food effect study. Links discussed in the show: • Here’s the current FDA guidance for food effect studies • You can connect with me on LinkedIn and send me a message • Send me a messa...

Podcast about clinical pharmacology (Ep 1) 03.07.2023 13:24

In my inaugural episode, I introduce myself, describe the type of clinical pharmacology and pharmacometrics content I will share, let you know how to get in touch with me, and give the reason why I started this podcast. Links discussed in the show: You can connect with me on LinkedIn and send me a message Send me a messsage Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Rese...