Dissolution and Translational Modeling Strategies Enabling Patient-Centric Drug Product Development: the M-CERSI Workshop Summary Report.

导出 LinkOut

翻译打印收藏纠错

作者： Andreas,Abend ^[1] ; Tycho,Heimbach ^[2] ; Michael,Cohen ^[3] ; Filippos,Kesisoglou ^[1] ; Xavier,Pepin ^[4] ; Sandra,Suarez-Sharp ^[5]

作者单位： Pharmaceutical Sciences, Merck, 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA. ^[1] Novartis Institutes for Biomedical Research, One Health Plaza, East Hanover, New Jersey, 07936, USA. ^[2] Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA. ^[3] AstraZeneca R&D, Macclesfield, Cheshire, UK. ^[4] Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Sandra.Suarez@fda.hhs.gov. ^[5]

关键词 IVIVC/IVIVR PBPK modeling and simulations clinically relevant specifications dissolution safe space

主题词人类(Humans);以病人为中心医护(Patient-Centered Care);溶解度(Solubility);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1208/s12248-018-0213-x

PMID 29633092

发布时间 2021-12-04

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交