CPT Pharmacometrics Syst Pharmacol May 2023 PMID 36631942

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview.

Andrew Babiskin, Fang Wu, Youssef Mousa, Ming-Liang Tan, Eleftheria Tsakalozou, Ross L Walenga, Miyoung Yoon, Sam G Raney, James E Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao

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Mentions

6
Peak: 2 in Aug 2021
across 2 sources since Aug 2021

Extended reach

1,451
potential audience

Total likes

12

Video views

9

Mentions per month

Aug 2021 – Aug 2023

Where it's discussed

  • X / Twitter5 posts
  • YouTube1 videos

AI synopsis

What people are saying

The social discussions emphasize the workshop's role in advancing mechanistic modeling for bioequivalence, with examples such as promotions for the virtual event and mentions of modeling techniques like PBPK, reflecting enthusiasm and recognition of its significance to regulatory science and industry practices.

AgreementModerate agreement

Most posts show support or positive acknowledgment of the workshop and its significance for bioequivalence assessment.

InterestHigh interest

The discussion demonstrates high intrigue about mechanistic modeling's role in regulatory science, indicated by calls to attend and promote the workshop.

EngagementModerate engagement

Posts actively share details about the event, including registration info, and promote discussions about modeling approaches, reflecting a moderate but genuine level of engagement.

ImpactModerate impact

The posts suggest the workshop could influence future regulatory practices and industry understanding of bioequivalence, highlighting its potential importance.

Abstract in brief

  • The workshop aimed to help the generic drug industry and regulators understand how mechanistic modeling techniques, like physiologically based pharmacokinetic and fluid dynamics models, can improve bioequivalence assessments and streamline drug approval processes.
  • It featured case studies and discussions to share current modeling practices, establish best practices, and promote the sharing of models through a new Model Master File to enhance collaboration between industry, regulators, and researchers.
  • Participants found the event useful, with increased understanding of scientific and regulatory aspects of mechanistic modeling, and there was clearer guidance on how these models should be validated and used in drug approval applications.]

Top posts

Most liked on X and Bluesky
M-CERSI
@MCERSI · X

Join the @US_FDA and @complexgenerics for a free virtual public workshop, "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches" on September 30 - October 1, 2021. Advanced registration is required. https://t.co/riGY4Bm49d https://t.co/0S0xyR7oeX

Aug 22, 2021 · 6 likes · 2 shares · 146 followers View post →
M-CERSI
@MCERSI · X

Don't miss next week's @US_FDA, @complexgenerics virtual workshop "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches." Email complexgenerics@rx.umaryland.edu with any questions, and RSVP to attend: https://t.co/AO2CTpc4ed https://t.co/NriW1iKnxm

Sep 20, 2021 · 4 likes · 146 followers View post →
Rosa for QSP
@RosaQSP · X

Bioequivalence workshop reports: PBPK modeling for assessing food impact https://t.co/BIwVb82uIQ PBPK modeling to support alternative bioequivalence & risk assessment https://t.co/qrQIAOpVNd Mechanistic modeling to support alternative bioequivalence https://t.co/1hCDzqHKUx

Jun 3, 2023 · 2 likes · 2 shares · 636 followers View post →
Fischell Institute for Biomedical Devices
@FischellInstUMD · X

RT @MCERSI: Join the @US_FDA and @complexgenerics for a free virtual public workshop, "Regulatory Utility of Mechanistic Modeling to Suppor…

Aug 23, 2021 · 2 shares · 463 followers View post →

All mentions

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 · 35 followers View post →
Rosa for QSP
@RosaQSP · X

Bioequivalence workshop reports: PBPK modeling for assessing food impact https://t.co/BIwVb82uIQ PBPK modeling to support alternative bioequivalence & risk assessment https://t.co/qrQIAOpVNd Mechanistic modeling to support alternative bioequivalence https://t.co/1hCDzqHKUx

Jun 3, 2023 · 2 likes · 2 shares · 636 followers View post →
M-CERSI
@MCERSI · X

Don't miss next week's @US_FDA, @complexgenerics virtual workshop "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches." Email complexgenerics@rx.umaryland.edu with any questions, and RSVP to attend: https://t.co/AO2CTpc4ed https://t.co/NriW1iKnxm

Sep 20, 2021 · 4 likes · 146 followers View post →
Fischell Institute for Biomedical Devices
@FischellInstUMD · X

RT @MCERSI: Join the @US_FDA and @complexgenerics for a free virtual public workshop, "Regulatory Utility of Mechanistic Modeling to Suppor…

Aug 23, 2021 · 2 shares · 463 followers View post →
M-CERSI
@MCERSI · X

Join the @US_FDA and @complexgenerics for a free virtual public workshop, "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches" on September 30 - October 1, 2021. Advanced registration is required. https://t.co/riGY4Bm49d https://t.co/0S0xyR7oeX

Aug 22, 2021 · 6 likes · 2 shares · 146 followers View post →