CPT Pharmacometrics Syst Pharmacol May 2023 PMID 36851886

Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report.

Ming-Liang Tan, Sajeev Chandran, Rebeka Jereb, Khondoker Alam, Robert Bies, Darby Kozak, Ross Walenga, Maxime Le Merdy, Andrew Babiskin

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Peak: 1 in Mar 2023

across 2 sources since Mar 2023

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Mar 2023 – Jan 2024

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What people are saying

The group shows overall positive dialogue about the article, highlighting its role in improving bioequivalence assessments for complex drug products like ophthalmic and nasal applications, with comments praising the workshop's focus on innovative modeling techniques and their regulatory significance. The tone varies from supportive to analytical, with phrases such as 'supporting the future of generic drugs' and 'essential for modern pharmacology' that underscore the perceived importance and potential influence of the research.

AgreementModerate agreement

Most discussions acknowledge the value of PBPK modeling in advancing generic drug development, reflecting support for the report’s insights.

InterestHigh interest

Participants demonstrate high interest by engaging with detailed aspects of mechanistic modeling and potential applications.

EngagementModerate engagement

While some posts briefly mention the report, others delve into specific implications, showing a moderate level of engagement.

ImpactModerate impact

The discussions recognize the potential of these modeling approaches to influence regulatory processes and streamline drug approval, indicating noticeable impact.

Abstract in brief

This workshop summary discusses how mechanistic modeling, like physiologically based pharmacokinetic (PBPK) modeling, can help evaluate the bioequivalence of locally acting generic drug products such as ophthalmic, nasal, injectable, and implant drugs, especially when traditional methods are impractical or unethical.
The US Food and Drug Administration's Office of Generic Drugs is promoting research programs to improve generic drug development and approval processes using model-based approaches that predict drug concentrations in local tissues, aiding in bioequivalence assessments.
The report covers presentations and discussions from a public workshop focused on the current use and future potential of PBPK modeling to streamline the approval of these specialized generic drug products.]

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Mechanistic Modeling Enhances Bioequivalence Assessment of Locally Acting Drugs

This workshop summary discusses how mechanistic modeling, like physiologically based pharmacokinetic modeling, can help evaluate the bioequivalence of ophthalmic, nasal, injectable, and implant drugs, particularly when…

Medicine RTCL TV · Aug 28, 2023 14 views

Simulations Plus

@SimulationsPlus · X

Catch up on the current state of the use of PBPK modeling approaches to support generic product development for ophthalmic, injectable, nasal, and implant drug products. Read more in this workshop summary report: https://t.co/pWBRi8V9RP https://t.co/J2UCoqdPQM

Jan 18, 2024 · 1 like · 909 followers View post →

Rosa for QSP

@RosaQSP · X

Jun 4, 2023 · 2 likes · 1 share · 640 followers View post →