Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.
作者信息
Tsakalozou Eleftheria, Gong Yuqing, Babiskin Andrew, Hu Meng, Mousa Youssef, Walenga Ross, Wu Fang, Yoon Miyoung, Raney Sam G, Polli James E, Schwendeman Anna, Krishnan Vishalakshi, Fang Lanyan, Zhao Liang
机构信息
Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
出版信息
AAPS J. 2024 Apr 24;26(3):55. doi: 10.1208/s12248-024-00924-8.
PMID:38658449
Abstract
摘要
Zotero 插件