Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report.

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Title: Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report.
Authors: McAllister M; Biowaived Ltd., Discovery Park, Sandwich CT13 9NJ, UK., Mistry N; GSK R&D, David Jack Research Centre, Harris's Lane, Ware SG12 0GX, UK., Pepin X; PBPK R&D, Simulations Plus, Inc., P.O. Box 12317, Research Triangle Park, NC 27709, USA., Cole S; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK., Tannergren C; Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, 43183 Gothenburg, Sweden., Stamatopoulos K; GSK R&D, David Jack Research Centre, Harris's Lane, Ware SG12 0GX, UK., Engman H; Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, 43183 Gothenburg, Sweden., Moir A; Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, UK., Litou C; Simcyp, Certara Predictive Technologies, Certara UK Ltd., Sheffield S1 2BJ, UK., Gavins F; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK., Arora S; Johnson & Johnson, Turnhoutseweg 32, 2340 Beerse, Belgium., Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK., Guimarães M; ESQlabs GmbH, 26683 Saterland, Germany., Ravi A; Pfizer Healthcare India Private Limited, IITM RESEARCH PARK, Kanagam, Tharamani, Chennai 600113, Tamil Nadu, India., Fotaki N; Department of Life Sciences, University of Bath, Bath BA2 7AY, UK., Dodd L; ESQlabs GmbH, 26683 Saterland, Germany., Holte Ø; Norwegian Medical Products Agency, 0663 Oslo, Norway., Butler J; GSK R&D, David Jack Research Centre, Harris's Lane, Ware SG12 0GX, UK., Dickinson PA; Seda Pharmaceutical Development Services, Unit 4 Oakfield Road, Cheadle Royal Business Park, Cheadle, Stockport SK8 3GX, UK., Popkin M; GSK R&D, Harris's Lane, Ware SG12 ODJ, UK., Butler A; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK., NiOgain O; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK., Holmstock N; Johnson & Johnson, Turnhoutseweg 32, 2340 Beerse, Belgium., Mackie C; Johnson & Johnson, Turnhoutseweg 32, 2340 Beerse, Belgium.
Source: Pharmaceutics [Pharmaceutics] 2026 May 01; Vol. 18 (5). Date of Electronic Publication: 2026 May 01.
Publication Type: Conference Proceedings; Journal Article
Journal Info: Publisher: MDPI Country of Publication: Switzerland NLM ID: 101534003 Publication Model: Electronic Cited Medium: Print ISSN: 1999-4923 (Print) Linking ISSN: 19994923 NLM ISO Abbreviation: Pharmaceutics Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report.
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  Data: <searchLink fieldCode="AU" term="%22McAllister+M%22">McAllister M</searchLink>; Biowaived Ltd., Discovery Park, Sandwich CT13 9NJ, UK.<br /><searchLink fieldCode="AU" term="%22Mistry+N%22">Mistry N</searchLink>; GSK R&D, David Jack Research Centre, Harris's Lane, Ware SG12 0GX, UK.<br /><searchLink fieldCode="AU" term="%22Pepin+X%22">Pepin X</searchLink>; PBPK R&D, Simulations Plus, Inc., P.O. Box 12317, Research Triangle Park, NC 27709, USA.<br /><searchLink fieldCode="AU" term="%22Cole+S%22">Cole S</searchLink>; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK.<br /><searchLink fieldCode="AU" term="%22Tannergren+C%22">Tannergren C</searchLink>; Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, 43183 Gothenburg, Sweden.<br /><searchLink fieldCode="AU" term="%22Stamatopoulos+K%22">Stamatopoulos K</searchLink>; GSK R&D, David Jack Research Centre, Harris's Lane, Ware SG12 0GX, UK.<br /><searchLink fieldCode="AU" term="%22Engman+H%22">Engman H</searchLink>; Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, 43183 Gothenburg, Sweden.<br /><searchLink fieldCode="AU" term="%22Moir+A%22">Moir A</searchLink>; Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield SK10 2NA, UK.<br /><searchLink fieldCode="AU" term="%22Litou+C%22">Litou C</searchLink>; Simcyp, Certara Predictive Technologies, Certara UK Ltd., Sheffield S1 2BJ, UK.<br /><searchLink fieldCode="AU" term="%22Gavins+F%22">Gavins F</searchLink>; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK.<br /><searchLink fieldCode="AU" term="%22Arora+S%22">Arora S</searchLink>; Johnson & Johnson, Turnhoutseweg 32, 2340 Beerse, Belgium.<br /><searchLink fieldCode="AU" term="%22Malamatari+M%22">Malamatari M</searchLink>; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK.<br /><searchLink fieldCode="AU" term="%22Guimarães+M%22">Guimarães M</searchLink>; ESQlabs GmbH, 26683 Saterland, Germany.<br /><searchLink fieldCode="AU" term="%22Ravi+A%22">Ravi A</searchLink>; Pfizer Healthcare India Private Limited, IITM RESEARCH PARK, Kanagam, Tharamani, Chennai 600113, Tamil Nadu, India.<br /><searchLink fieldCode="AU" term="%22Fotaki+N%22">Fotaki N</searchLink>; Department of Life Sciences, University of Bath, Bath BA2 7AY, UK.<br /><searchLink fieldCode="AU" term="%22Dodd+L%22">Dodd L</searchLink>; ESQlabs GmbH, 26683 Saterland, Germany.<br /><searchLink fieldCode="AU" term="%22Holte+Ø%22">Holte Ø</searchLink>; Norwegian Medical Products Agency, 0663 Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Butler+J%22">Butler J</searchLink>; GSK R&D, David Jack Research Centre, Harris's Lane, Ware SG12 0GX, UK.<br /><searchLink fieldCode="AU" term="%22Dickinson+PA%22">Dickinson PA</searchLink>; Seda Pharmaceutical Development Services, Unit 4 Oakfield Road, Cheadle Royal Business Park, Cheadle, Stockport SK8 3GX, UK.<br /><searchLink fieldCode="AU" term="%22Popkin+M%22">Popkin M</searchLink>; GSK R&D, Harris's Lane, Ware SG12 ODJ, UK.<br /><searchLink fieldCode="AU" term="%22Butler+A%22">Butler A</searchLink>; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK.<br /><searchLink fieldCode="AU" term="%22NiOgain+O%22">NiOgain O</searchLink>; Medicines & Healthcare Products Regulatory Agency, 10 South Colonnade, London E14 4PU, UK.<br /><searchLink fieldCode="AU" term="%22Holmstock+N%22">Holmstock N</searchLink>; Johnson & Johnson, Turnhoutseweg 32, 2340 Beerse, Belgium.<br /><searchLink fieldCode="AU" term="%22Mackie+C%22">Mackie C</searchLink>; Johnson & Johnson, Turnhoutseweg 32, 2340 Beerse, Belgium.
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