25本のエピソード
Clinical Pharmacology Podcast with Nathan Teuscher Nathan Teuscher
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- 科学
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5.0 • 1件の評価
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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.
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Biosimilar products (Ep. 25)
Today’s show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of interchangeability between the biosimilar and reference products.
Links discussed in the show:
FDA Guidance on Clinical Pharmacology Data to support Biosimilarity (May 2016)
FDA Guidance on Demonstrating Interchangeability (May 2019)
FDA Q&A on Biosimilarity and Interchangeability (Sep 2023)
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Choosing an absorption model (Ep. 24)
Today’s show discussed approaches for modeling absorption profiles. I discussed the rationale behind modeling absorption and then described some common models. These included first-order absorption, zero-order absorption, transit compartments, distributed delay, Weibull, and zero/first order absorption. I also provided my recommendations on how to model absorption.
Links discussed in the show:
Distributed delay modeling in PK and PD
Modeling biphasic formulation of methylphenidate
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What is Aplos NCA? (Ep. 23)
Today’s show was an overview of Aplos Analytics and the development story for Aplos NCA. Please consider participating in the Early Access Program. Use the link below to learn more about Aplos NCA.
Links discussed in the show:
Aplos Analytics website
Aplos Analytics Contact Us Page
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Big announcement and Hepatic impairment studies (Ep. 22)
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)
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
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Tackling TMDD Models (Ep. 20)
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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Copyright Teuscher Solutions LLC
All Rights Reserved