Clinical Pharmacology Podcast with…

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https://go.teuschersolutions.com/linkedin
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https://www.linkedin.com/in/michaelpiperno/
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https://www.linkedin.com/in/julie-bullock-ba6826/
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https://github.com/Detlew/PowerTOST
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https://github.com/nlmixr2
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Liste des épisodes récents, avec titres, durées et descriptions.

Direct effect PKPD models (Ep. 32)

Épisode 32

lundi 26 août 2024 • Durée 31:34

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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What should you use to present PK results? (Ep. 31)

Épisode 31

lundi 12 août 2024 • Durée 31:24

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
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Big announcement and Hepatic impairment studies (Ep. 22)

Épisode 22

lundi 25 mars 2024 • Durée 18:03

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
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Project Optimus (Ep. 21)

Épisode 21

lundi 11 mars 2024 • Durée 39:29

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
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Tackling TMDD Models (Ep. 20)

Épisode 20

lundi 26 février 2024 • Durée 15:48

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:

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Communication for scientists (Ep. 19)

Épisode 19

lundi 12 février 2024 • Durée 46:15

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
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Cell Therapy and Clinical Pharmacology (Ep. 18)

Épisode 18

lundi 22 janvier 2024 • Durée 13:11

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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Allometry in Pediatrics and First in Human Studies (Ep. 17)

Épisode 17

lundi 8 janvier 2024 • Durée 17:11

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
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Computer System Validation for Pharmacometrics (Ep. 16)

Épisode 16

lundi 25 décembre 2023 • Durée 30:13

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:

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QSP, PBPK, PKPD, PopPK … analysis abbreviation soup! (Ep. 15)

Épisode 15

lundi 11 décembre 2023 • Durée 26:10

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:

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