Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan

被引：0
|
作者：
Eiji Kajiwara
Haruki Kamizato
Mayumi Shikano
机构：
[1] Kitanomaru Square,MSD K.K
[2] Tokyo University of Science,Department of Pharmaceutical Sciences
来源：
Therapeutic Innovation & Regulatory Science | 2020年 / 54卷
关键词：
Recall; Quality by design (QbD); Review period; Real time release testing (RTRT); Design space;
D O I：
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中图分类号：
学科分类号：
摘要：
引用
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页码：1192 / 1198
页数：6
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