Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.

Abdullah Al Shoyaib, Arian Emami Riedmaier, Anita Kumar, Partha Roy, Neil John Parrott, Lanyan Fang, Nilufer Tampal, Yuching Yang, Rebeka Jereb, Liang Zhao, Fang Wu

May 2023 CPT Pharmacometrics Syst Pharmacol

Synopsis of Social media discussions

The overall tone of the discussions indicates a recognition of PBPK modeling as a valuable tool, with mentions of its role in regulatory support and bioequivalence assessment. Words like 'support' and references to workshops and mini-reviews highlight an engagement that is thoughtful and oriented toward practical applications, though not highly enthusiastic or critical.

A
Agreement
 Moderate agreement

Most discussions acknowledge the importance and potential of PBPK modeling in the context of bioequivalence, reflecting general support.

I
Interest
 Moderate level of interest

Participants show moderate curiosity, with some sharing resources like mini-reviews, indicating a genuine interest without overwhelming enthusiasm.

E
Engagement
 Moderate level of engagement

The comments reference specific methods like mechanistic modeling and include mentions of workshop reports, suggesting active but measured engagement.

I
Impact
 Moderate level of impact

The focus on advancing regulatory tools and supporting alternative methods demonstrates recognition of the potential impact on pharmaceutical development processes.

Social Mentions

YouTube

1 Videos

Facebook

2 Posts

Twitter

4 Posts

Metrics

Video Views

57

Total Likes

3

Extended Reach

3,228

Social Features

7

Timeline: Posts about article

Top Social Media Posts

Posts referencing the article

Regulatory Role of PBPK Modeling in Food Impact Assessment for Bioequivalence

Regulatory Role of PBPK Modeling in Food Impact Assessment for Bioequivalence

This workshop report highlights the use of physiologically based pharmacokinetic modeling to evaluate food effects on drug bioavailability, supporting regulatory decisions and advancements in generic drug development.

Medicine RTCL TV

September 6, 2023

57 views

  • ASCPT Journal Family
    @ASCPTjournals (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 5, 2023

    2

  • Pietro Fagiolino
    @pietrofagiolino (Twitter)

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

    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

  • ASCPT Alexandria
    @ASCPT_ClinPharm (Twitter)

    Check out this mini-review from #PSPjournal: https://t.co/4M40qCs6mM
    view full post

    June 1, 2023

Abstract Synopsis

  • - The workshop report focuses on presentations and discussions about using physiologically based pharmacokinetic (PBPK) modeling for assessing food effects on drug bioavailability and bioequivalence, stemming from a specific session at a workshop organized by the FDA and the Center for Research on Complex Generics.
  • - PBPK modeling is gaining traction among researchers, industry professionals, and regulatory agencies due to its effectiveness in studying how food impacts the absorption and equivalence of new and generic drugs.
  • - The session aimed to share knowledge and address gaps in understanding PBPK modeling, with the goal of supporting further advancements in its application for generic drug development.