PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report

Tycho Heimbach,Flora Musuamba Tshinanu,Kimberly Raines, Luiza Borges,Shinichi Kijima,Maria Malamatari,Rebecca Moody,Shereeni Veerasingham,Paul Seo,David Turner,Lanyan Fang,Cordula Stillhart,Philip Bransford,Xiaojun Ren,Nikunjkumar Patel,David Sperry, Hansong Chen,Amin Rostami-Hodjegan,Viera Lukacova,Duxin Sun, Jean-Flaubert Nguefack, Tessa Carducci, Manuela Grimstein,Xavier Pepin,Masoud Jamei,Konstantinos Stamatopoulos, Min Li,Maitri Sanghavi,Christer Tannergren,Haritha Mandula, Zhuojun Zhao, Tzuchi Rob Ju,Christian Wagner,Sumit Arora,Michael Wang,Gregory Rullo,Amitava Mitra,Sivacharan Kollipara,Siri Kalyan Chirumamilla,James E. Polli,Claire Mackie

MOLECULAR PHARMACEUTICS（2024）

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Key words

Bioequivalence,bioequivalence safe space,context of use,dissolution,drug product quality,IVIVC,IVIVR,model credibility assessmentframework,modeling,PBBM

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