Clinical Pharmacology Podcast with Nathan Teuscher – Details, episodes & analysis

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 models, how to set up the dataset for NONMEM, and how to code the model in NONMEM. This is the first of 4 episodes on different PK-PD models.

Links discussed in the show:

• Example NONMEM code for direct effect model
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In this episode I discuss different methods of presenting pharmacokinetic and pharmacometrics results. I spoke about using PowerPoint and R Markdown derived HTML files. While I prefer HTML files in nearly all cases, I appreciate that sometimes PowerPoint format is required by some companies. I included multiple suggestions for both PowerPoint and HTML files that can help make the information presentation more effective.

Links discussed in the show:

• Floating table of contents in R Markdown HTML output
• How to include CSS in your R Markdown
• Creating tabs in R Markdown
• Code folding in R Markdown
• You can connect with me on LinkedIn and send me a message
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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 send me a message
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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 Selection Strategies in Oncology
• Sept 2023 Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right (this one focused on combinations)
• Feb 2024 FDA/AACR Public Workshop: Optimizing Dosages for Oncology Drugs
• You can connect with Julie on LinkedIn
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter

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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
• Dynamics of target-mediated drug disposition: characteristic profiles and parameter identification
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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 Michael’s newsletter
• View upcoming leadership and communication workshops

You can connect with me

• You can connect with me on ⁠LinkedIn and send me a message⁠⁠
• Send me a message⁠⁠
• Sign up for my newsletter⁠

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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

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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
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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 guidance on computer systems and electronic data in clinical trials
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter

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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

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