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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report by Amitava Mitra; Sandra Suarez-Sharp; Xavier J.H. Pepin; Talia Flanagan; Yang Zhao; Evangelos Kotzagiorgis; Neil Parrott; Satish Sharan; Christophe Tistaert; Tycho Heimbach; Banu Zolnik; Erik Sjögren; Fang Wu; Om Anand; Shefali Kakar; Min Li; Shereeni Veerasingham; Shinichi Kijima; Gustavo Mendes Lima Santos; Baoming Ning; Kimberly Raines; Greg Rullo; Haritha Mandula; Poonam Delvadia; Jennifer Dressman; Paul A. Dickinson; Andrew Babiskin is a Chemistry article available to read on EtoBox.

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This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality perspective, patient-centric product development necessitates the development of clinically relevant drug product specifications (CRDPS). In this regard, Physiologically Based Biopharmaceutics modeling (PBBM) is a viable tool to establish links between in-vitro to in-vivo data, and support with establishing CRDPS. The theme of day 3 was practical applications of PBBM to support drug product quality. In this manuscript, case studies from US FDA, EMA and pharmaceutical industry on applications of PBBM in drug product quality are summarized which include 1) regulatory agency's perspectives on establishing the safe space and achieving study waivers, 2) model-informed risk assessment on the effects of acid reducing agents, bridging of dissolution methods, food effect, and formulation selection, and 3) understanding clinical formulation performance. Breakout session discussions focused on four topics - 1) terminologies related to physiologicall

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Author

Amitava Mitra; Sandra Suarez-Sharp; Xavier J.H. Pepin; Talia Flanagan; Yang Zhao; Evangelos Kotzagiorgis; Neil Parrott; Satish Sharan; Christophe Tistaert; Tycho Heimbach; Banu Zolnik; Erik Sjögren; Fang Wu; Om Anand; Shefali Kakar; Min Li; Shereeni Veerasingham; Shinichi Kijima; Gustavo Mendes Lima Santos; Baoming Ning; Kimberly Raines; Greg Rullo; Haritha Mandula; Poonam Delvadia; Jennifer Dressman; Paul A. Dickinson; Andrew Babiskin

Publisher

Elsevier BV

Published

2020

Language

EN

Field

Chemistry (Physical Sciences)