Approaches for promoting regulatory science in PMDA
نویسندگان
چکیده
منابع مشابه
Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors' submissions and contribute to the PMDA's research. In this article, we summarize the number of submissions of quantitative modeling and simulation (M&S) documents in NDAs i...
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ژورنال
عنوان ژورنال: Folia Pharmacologica Japonica
سال: 2016
ISSN: 0015-5691,1347-8397
DOI: 10.1254/fpj.148.9