Regulatory review time for approval of oncology drugs in Japan between 2001 and 2014. Considerations of changes, factors that affect review time, and difference with the United States-Reference-Cited by-同舟云学术

Regulatory review time for approval of oncology drugs in Japan between 2001 and 2014. Considerations of changes, factors that affect review time, and difference with the United States

Published:2015-02-04 Issue:5 Volume:55 Page:481-489
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Maeda Hideki¹²,Kurokawa Tatsuo¹

Affiliation:

1. Division of Drug Development and Regulatory Science, Graduate School of Pharmaceutical Sciences; Keio University, 1-5-30, Shibakoen, Minato-ku; Tokyo Japan

2. Oncology, Clinical Development Department; Global Development, Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku; Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

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3. Comparison of Addition of Indications for Antineoplastic Agents Approved in the United States and Japan from 2001 to 2020;Biological and Pharmaceutical Bulletin;2023-07-01

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