Ren, Xiaojun (2024) PBBM Considerations for Base Models, Model Validation and Application Steps: Workshop Summary Report. Molecular pharmaceutics, 21 (11). pp. 5353-5372. ISSN 1543-8384

Abstract

The proceedings from the 30th August 2023 (Day 2) of the workshop “Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives” are provided herein. Day 2 covered PBBM case studies from six regulatory authorities which provided considerations for model verification, validation and application based on the context of use (COU) of the model. PBBM case studies to define critical material attribute (CMA) specification settings such as active pharmaceutical ingredient (API) particle size distributions (PSD) were shared. PBBM case studies to define critical quality attributes (CQA) such as dissolution specification setting or to define the bioequivalence safe space were discussed. PBBM COU examples are described.
Breakout session discussions highlighted current trends and barriers to application of PBBMs including: a) PBBM credibility assessment framework and level of validation, b) use of disposition parameters in PBBM and points to consider when IV data are not available, c) conducting virtual bioequivalence trials and dealing with variability, d) model acceptance criteria and e) application of PBBMs for establishing safe space and failure edges. Examples of PBBM using the credibility assessment framework, COU and model risk assessment as well as scientific learnings from PBBM case studies are provided.

Item Type:	Article
Date Deposited:	28 Jan 2025 00:45
Last Modified:	28 Jan 2025 00:45
URI:	https://oak.novartis.com/id/eprint/54261