Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions
基于生理学的生物制药模型开发报告模板:为满足监管申报要求而需考虑的质量改进问题
期刊:Molecular Pharmaceutics
影响因子:4.5
doi:10.1021/acs.molpharmaceut.5c00225
Arora, Sumit; Pepin, Xavier; Jamei, Masoud; Sharma, Pradeep; Heimbach, Tycho; Wagner, Christian; Bransford, Philip; Kollipara, Sivacharan; Ahmed, Tausif; Hingle, Martin; Dallmann, André; Scherholz, Megerle; Stamatis, Stephen D; Cano-Vega, Mario; Mistry, Nena; Tannergren, Christer; Borges, Luiza; Lindahl, Anders; Rullo, Gregory; Mackie, Claire; Mitra, Amitava; Kushner, Joseph; Harish Jain, Krutika Meena; Polli, James E