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

May 2023 CPT Pharmacometrics Syst Pharmacol

Synopsis of Social media discussions

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.

A
Agreement
 Moderate agreement

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

I
Interest
 High level of interest

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

E
Engagement
 Moderate level of 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.

I
Impact
 Moderate level of impact

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

Social Mentions

YouTube

1 Videos

Twitter

5 Posts

Metrics

Video Views

9

Total Likes

12

Extended Reach

1,451

Social Features

6

Timeline: Posts about article

Top Social Media Posts

Posts referencing the article

Using Mechanistic Modeling to Support Alternative Bioequivalence Approaches

Using Mechanistic Modeling to Support Alternative Bioequivalence Approaches

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.

Medicine RTCL TV

August 26, 2023

9 views

  • Pietro Fagiolino
    @pietrofagiolino (Twitter)

    RT @RosaQSP: Bioequivalence workshop reports: PBPK modeling for assessing food impact https://t.co/BIwVb82uIQ PBPK modeling to support alte…
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    June 3, 2023

    2

  • Rosa for QSP
    @RosaQSP (Twitter)

    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
    view full post

    June 3, 2023

    2

    2

  • M-CERSI
    @MCERSI (Twitter)

    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
    view full post

    September 20, 2021

    4

  • Fischell Institute for Biomedical Devices
    @FischellInstUMD (Twitter)

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

    August 23, 2021

    2

  • M-CERSI
    @MCERSI (Twitter)

    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
    view full post

    August 22, 2021

    6

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Abstract Synopsis

  • 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.]