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 newsletter

Copyright Teuscher Solutions LLC

All Rights Reserved

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 Guidance (FDA website)

• Scientific white paper on concentration – QTc modeling by Garnett et. al

• Correction to publication

• 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

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 conclude with a discussion of how to use physiologic-based pharmacokinetic models for pediatric extrapolation.

Links discussed in the show:

• Baby arms over head video

• PBPK Models in Pediatric Development

• 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

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 design. And I will end with some unique challenges related to bioequivalence. Throughout, I will give practical suggestions based on my experiences in the past with BE studies.

Links discussed in the show:

• EMA guidance on bioequivalence

• FDA guidance on statistical approaches to bioequivalence (December 2022)

• FDA statistical approaches to BE (January 2001)

• FDA guidance on BE studies (2022)

• FDA product-specific guidances on BE

• Lecture from Helmut Schütz on finding intra-subject variability (or CV%) for power calculations

• PowerTOST R Package

• 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

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.

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

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:

Copyright Teuscher Solutions LLC

All Rights Reserved

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

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:

Copyright Teuscher Solutions LLC

All Rights Reserved