Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Author:

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

Funder

Center of Excellence in Regulatory Science and Innovation

CERSI

University of Maryland

US Food & Drug Administration

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference13 articles.

1. Current state and future expectations of translational modeling strategies to support drug product development, manufacturing changes and controls: a workshop summary report;Pepin;J Pharm Sci,2020

2. Clinical relevance of dissolution testing in quality by design;Dickinson;AAPS J,2008

3. Dissolution and translational modeling strategies toward establishing an in vitro-in vivo link—a workshop summary report;Heimbach;AAPS J,2019

4. Dissolution and translational modeling strategies enabling patient-centric drug product development: the M-CERSI workshop summary report;Abend;AAPS J,2018

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