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Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report Tsakalozou, Eleftheria; Fang, Lanyan; Skoda, Erin; Nicholas, Timothy; Kollipara, Sivacharan; Ren, Ke; Grosser, Stella; Rege, Bhagwant; Roy, Partha; Zhu, Hao; Zhao, Liang 分享 收藏
Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization Cheng, Yi-Hsien; Thomas, Sherin; Tsang, Yu Chung; Almeida, Susana; Ashraf, Muhammad; Fotaki, Nikoletta; Heimbach, Tycho; Patel, Nikunjkumar; Shah, Harshil; Jiang, Xiaojian; Kim, Myong-Jin; Moody, Rebecca; Rostami-Hodjegan, Amin; Singh, Romi; Zhao, Liang; Babiskin, Andrew; Wu, Fang 分享 收藏
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A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: Paving the road towards fed state virtual BE studies for itraconazole amorphous solid dispersions 基于生理的生物药剂学建模 (PBBM) 框架,用于表征依赖于配方的食物效应: 为伊曲康唑无定形固体分散体的进食状态虚拟BE研究铺平道路 Rudolph, Niklas; Charbe, Nitin; Plano, David; Al Shoyaib, Abdullah; Pal, Arindom; Boyce, Heather; Zhao, Liang; Wu, Fang; Polli, James; Dressman, Jennifer; Cristofoletti, Rodrigo 分享 收藏
Exploration of the potential impact of batch-to-batch variability on the establishment of pharmacokinetic bioequivalence for inhalation powder drug products Li, Shuhui; Feng, Kairui; Lee, Jieon; Gong, Yuqing; Wu, Fang; Newman, Bryan; Yoon, Miyoung; Fang, Lanyan; Zhao, Liang; Gobburu, Jogarao V. S. 分享 收藏
Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations Donnelly, Mark; Fang, Lanyan; Madabushi, Rajanikanth; Zhu, Hao; Luke, Markham; Canterbury, Crystal; Lerman, Bruce; Kaur, Paramjeet; Patel, Devvrat; Sun, Wanjie; Schuirmann, Don; Dinsmore, Steven; Mehta, Mehul; Zhao, Liang 分享 收藏
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Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances Lu, Dongmei; Rege, Bhagwant; Raw, Andre; Yang, Jingyue; Alam, Khondoker; Bode, Chris; Zhao, Liang; Faustino, Patrick; Wu, Fang; Shakleya, Diaa; Nickum, Elisa; Li, Bing V.; Wang, Rong; Stier, Ethan; Miezeiewski, Blair; Patel, Rachana; Boam, Ashley; Lionberger, Robert; Keire, David; Yu, Lawrence 分享 收藏