Reforms of regulatory pathways for approval of new antineoplastic drugs in Japan from 2004 to 2019 and accompanying changes in pivotal clinical trial designs-Reference-Cited by-同舟云学术

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Reforms of regulatory pathways for approval of new antineoplastic drugs in Japan from 2004 to 2019 and accompanying changes in pivotal clinical trial designs

Published:2021-08-21 Issue:1 Volume:40 Page:142-150
ISSN:0167-6997
Container-title:Investigational New Drugs
language:en
Short-container-title:Invest New Drugs

Author:

Hirai Takehiro,Suzuki Asuka,Yamori Takao,Matsuura Masaaki

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Oncology

Link

https://link.springer.com/content/pdf/10.1007/s10637-021-01165-8.pdf

Reference36 articles.

1. PMDA (2005) https://www.pmda.go.jp/english/about-pmda/outline/0002.html. Accessed 22 Mar 2021

2. Ministry of Internal Affairs and Communications (MIC) (1960) https://elaws.e-gov.go.jp/document?lawid=335AC0000000145 (Japanese). Accessed 22 Mar 2021

3. Ministry of Health, Labour and Welfare (MHLW) (1961) https://www.mhlw.go.jp/web/t_doc?dataId=81006000&dataType=0&pageNo=1 (Japanese). Accessed 22 Mar 2021

4. Ministry of Health, Labour and Welfare (MHLW) (1993) https://www.mhlw.go.jp/web/t_doc?dataId=00ta6846&dataType=1&pageNo=1 (Japanese). Accessed 22 Mar 2021

5. Ministry of Health, Labour and Welfare (MHLW) (1999) https://www.mhlw.go.jp/shingi/2005/01/dl/s0124-9h1.pdf (Japanese). Accessed 22 Mar 2021

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