CPT Pharmacometrics Syst Pharmacol May 2023 PMID 36330693

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report.

Ross L Walenga, Clare Butler, Brent A Craven, P Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V Li, Markham C Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger

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Peak: 2 in Aug 2023

across 2 sources since Jun 2023

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AI synopsis

What people are saying

Throughout the discussions, there is a clear consensus on the significance of the report, with participants mentioning how mechanistic models could advance generic inhaled drug approval processes and improve safety profiles. The tone uses words like 'crucial,' 'promising,' and 'future of' to underscore the perceived positive influence and evolving interest in this area.

AgreementModerate agreement

Most discussions express support for the importance and relevance of the report, indicating a general agreement with its goals and conclusions.

InterestHigh interest

Participants show high enthusiasm and curiosity about mechanistic modeling's role in inhaled drug development, reflected in positive language around innovation.

EngagementModerate engagement

Comments include references to other types of modeling and the broader implications of the workshop, demonstrating moderate depth of engagement.

ImpactModerate impact

Several discussions highlight the potential for these models to streamline approval processes and improve safety, suggesting a perceived moderate impact.

Abstract in brief

This report summarizes a workshop focused on how computer-based (in silico) mechanistic models can help develop and get approval for generic inhaled drug products by predicting how these drugs behave in the body.
It discusses the different types of models created by various stakeholders, their current status, and ways to verify and establish their reliability for use in regulatory decisions.
The goal of these models is to support ensuring that generic inhaled medications are safe and effective, streamlining their development process.]

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All mentions

Mechanistic Modeling of Inhaled Generic Drugs for Regulatory Approval

This workshop summary discusses how computer-based mechanistic models can predict drug behavior in the body to support the development and approval of generic inhaled medications, streamlining their regulatory process.

Medicine RTCL TV · Aug 20, 2023 24 views

GaBI

@GaBIOnline_ · X

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report Walenga RL, et al. CPT Pharmacometrics Syst Pharmacol. 2023 May; https://t.co/GSVZVxqp7b

Aug 23, 2023 · 1,441 followers View post →

Rosa for QSP

@RosaQSP · X

Jun 4, 2023 · 2 likes · 1 share · 635 followers View post →