CPT Pharmacometrics Syst Pharmacol May 2023 PMID 36530026

Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.

Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong-Jin Kim, Jianghong Fan, Banu S Zolnik

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Mentions

Peak: 2 in Jun 2023

across 2 sources since Jun 2023

Extended reach

717

potential audience

Total likes

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Mentions per month

Jun 2023 – Aug 2023

Where it's discussed

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YouTube1 videos

AI synopsis

What people are saying

The discussions show enthusiasm for PBPK modeling's role in advancing bioequivalence assessment, with phrases like 'support alternative bioequivalence' and 'foster model-sharing' highlighting the relevance of the report's findings, while the tone emphasizes both the technical challenges and potential regulatory impacts.

AgreementModerate agreement

Most discussions acknowledge the significance of PBPK modeling in bioequivalence and support its use in regulatory and product development contexts.

InterestHigh interest

Posts demonstrate high interest by focusing on key topics like food impact, risk assessment, and industry practices, reflecting engagement with current scientific debates.

EngagementModerate engagement

Comments include mentions of model sharing, industry challenges, and case studies, indicating active participation and thoughtful engagement.

ImpactModerate impact

The discussions suggest that the workshop outputs could influence regulatory approaches and modeling standards, emphasizing practical implications.

Abstract in brief

The report highlights discussions from day 2 of a workshop on using mechanistic modeling, specifically physiologically-based pharmacokinetic (PBPK) modeling, to enhance bioequivalence assessments for generic drugs.
Key topics included how PBPK modeling can aid in product development, regulatory submissions, and evaluating the effects of food on bioequivalence, alongside presenting successful case studies and challenges faced in the field.
The report also focuses on the establishment of best practices for PBPK modeling and the introduction of a Model Master File to foster model-sharing within the industry.

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All mentions

Physiologically-Based Pharmacokinetic Modeling for Bioequivalence Support

The report highlights discussions on using mechanistic PBPK modeling to enhance bioequivalence assessments for generics, aiding product development, regulatory submissions, and evaluating food effects, with case studies…

Medicine RTCL TV · Aug 17, 2023 36 views

Pietro Fagiolino

@pietrofagiolino · X

RT @RosaQSP: Bioequivalence workshop reports: PBPK modeling for assessing food impact https://t.co/BIwVb82uIQ PBPK modeling to support alte…

Jun 3, 2023 · 2 shares · 36 followers View post →

Rosa for QSP

@RosaQSP · X

Jun 3, 2023 · 2 likes · 2 shares · 637 followers View post →