Ren, Xiaojun (2024) Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. the journal Molecular Pharmaceutics, XXX (XXX). XXX-XXX. ISSN 1543-8384

Abstract

This article shares the proceedings from the 29th August 2023 (day 1) of the workshop “Physiologically Based Biopharmaceutics Models (PBBM): Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”. The focus of the day was on model parameterization, regulatory authorities from Canada, the USA, Sweden, Belgium and Norway presented their view on PBBM case studies submitted by industry members of the IQ consortium. The presentations shared key questions raised by regulators during the mock exercise, regarding the PBBM input parameters and their justification. These presentations also shed light on the regulatory assessment process, content and format requirements for future PBBM regulatory submissions. In addition, the day 1 breakout presentations and discussions gave the opportunity to share best practices around key questions faced by scientists when parameterizing PBBMs. Key questions included measurement and integration of drug substance solubility for crystalline vs. amorphous drugs; impact of excipients on apparent drug solubility / supersaturation; modeling of acid-base reactions at the surface of the dissolving drug; choice of dissolution methods according to the formulation and drug properties with a view to prediction of the in vivo performance; mechanistic modeling of in vitro product dissolution data to predict in vivo dissolution for various patient populations / species; best practices for characterization of drug precipitation from simple or complex formulations and integration of the data in a PBBM; incorporation of drug permeability into PBBM for various routes of uptake and prediction of permeability along the GI tract.

Item Type:	Article
Date Deposited:	13 Jul 2024 00:46
Last Modified:	13 Jul 2024 00:46
URI:	https://oak.novartis.com/id/eprint/53177