Application of Real-World Evidence to Support FDA Regulatory Decision Making

被引：0
|
作者：
Vipada Khaowroongrueng [1 ]
Tae-Eun Kim [2 ]
Sang-In Park [3 ]
Kwang-Hee Shin [4 ]
机构：
[1] The Government Pharmaceutical Organization,Research Development and Innovation Department
[2] Konkuk University Medical Center,Department of Clinical Pharmacology
[3] Kangwon National University,Department of Pharmacology, College of Medicine
[4] Kyungpook National University,College of Pharmacy, Research Institute of Pharmaceutical Sciences
[5] Kyungpook National University,Infectious Disease Healthcare
来源：
The AAPS Journal | / 27卷 / 4期
关键词：
FDA; real-world evidence; regulatory decision making;
D O I：
10.1208/s12248-025-01082-1
中图分类号：
学科分类号：
摘要：
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