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Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link: a Workshop Summary Report
Novartis Inst BioMed Res, Dept PK Sci, PBPK & Biopharmaceut Sect, E Hanover, NJ USA.
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA.
Janssen Res & Dev, Pharmaceut Sci, Small Mol Pharmaceut Dev, Beerse, Belgium.
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2019 (English)In: AAPS Journal, ISSN 1550-7416, E-ISSN 1550-7416, Vol. 21, no 2, article id 29Article in journal (Refereed) Published
Abstract [en]

This publication summarizes the proceedings of day 2 of a 3-day workshop on Dissolution and Translational Modeling Strategies Enabling Patient-Centric Product Development. Patient-centric drug product development from a drug product quality perspective necessitates the establishment of clinically relevant drug product specifications via an in vitro-in vivo link. Modeling and simulation offer a path to establish this link; in this regard, physiologically based modeling has been implemented successfully to support regulatory decision-making and drug product labeling. In this manuscript, case studies of physiologically based biopharmaceutics modeling (PBBM) applied to drug product quality are presented and summarized. These case studies exemplify a possible path to achieve an in vitro-in vivo link and encompass (a) development of biopredictive dissolution methods to support biowaivers, (b) model-informed formulation selection, (c) predicting clinical formulation performance, and (d) defining a safe space for regulatory flexibility via virtual bioequivalence (BE). Workflows for the development and verification of absorption models/PBBM and for the establishment of a safe space using dissolution as an input are described with examples. Breakout session discussions on topics, such as current challenges and some best practices in model development and verification, are included as part of the Supplementary material.

Place, publisher, year, edition, pages
SPRINGER , 2019. Vol. 21, no 2, article id 29
Keywords [en]
clinically relevant dissolution specifications, IVIVC, IVIVR, physiologically based biopharmaceutics modeling (PBBM), safe space, virtual bioequivalence
National Category
Pharmacology and Toxicology Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-378626DOI: 10.1208/s12248-019-0298-xISI: 000458466000001PubMedID: 30746576OAI: oai:DiVA.org:uu-378626DiVA, id: diva2:1295316
Available from: 2019-03-11 Created: 2019-03-11 Last updated: 2019-03-11Bibliographically approved

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