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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

00:24:40

Exposure-Response FDA Guidance (Ep. 10)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/09/25

This episode is a discussion of the FDA guidance “Exposure-Response Relationships”. The relationship between drug exposure and response is critical to any determination of the safety and effectiveness of a drug product. In this episode I discuss the regulatory applications of exposure-response, the exposure-response relationships over time, the design of studies to collection exposure-response information, and modeling exposure-response relationships. Links discussed in the show: • FDA guidance

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00:43:24

Finding a job in Clinical Pharmacology (Ep. 9)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/09/11

This episode I talk about finding a job in Clinical Pharmacology or Pharmacometrics. I share a few thoughts from my experience followed by an interview with TJ Elder, the president of STEM Sourcing Recruiting and Staffing. TJ shares his insights and best practices on securing a new job in Clinical Pharmacology or Pharmacometrics. Links discussed in the show: • Connect with TJ Elder on LinkedIn • You can connect with me on LinkedIn and send me a message • Send me a message • Sign up for my

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00:30:37

QT Prolongation Guidance ICH E14 (Ep. 8)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/08/28

This episode is a discussion of the FDA and ICH guidance E14 titled “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”. I start with background on the reason for these evaluations, then move to an overview of the key evaluations needed. I then discuss in some detail the thorough QT study and the concentration QT analysis. Then I provide some parting thoughts from my experiences with these analyses. Links discussed in the show: • ICH E14

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00:24:51

Pediatric Extrapolation (Ep. 7)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/08/14

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 patients and the extrapolation of adult exposure-response or pharmacodynamic data to pediatrics. And I

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00:30:14

Bioequivalence Guidances from FDA and EMA (Ep. 6)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/07/24

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. Then I will discuss the statistical basis for bioequivalence and how you can leverage that for study

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00:20:26

Nuances of NCA (Ep. 5)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/07/10

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 in the show: Images mentioned in the podcast Derivation of logarithmic AUC Calculating the elimination

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00:36:06

Population PK FDA guidance (Ep. 4)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/07/03

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 Reserved

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00:17:44

Comparing NCA and PK models (Ep. 3)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/07/03

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’s a link to the Dexcom glucose sensor and the Tandem T-slim insulin pump You can connect with

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00:17:55

Food Effect FDA Guidance (Ep 2)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/07/03

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 message • Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

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00:13:24

Podcast about clinical pharmacology (Ep 1)

Clinical Pharmacology Podcast with Nathan Teuscher ·

2023/07/03

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 Reserved

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50 results

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