Author:
Ono Shunsuke,Yoshioka Chisato,Asaka Orie,Tamura Koji
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)
Reference15 articles.
1. Fujiwara Y. MD reviewers’ role in the new anticancer drug approval process in the newly established Japanese regulatory agency, PMDEC. Jpn J Clin Oncol. 1998;28:653–656.
2. Fujiwara Y, Kobayashi K. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC). Critical Rev Oncol Hematol. 2002;42:145–155.
3. Pharmaceutical and Medical Devices Agency. Press release on the new review agency [in Japanese]. http://www.pmda.go.jp/hpress_31.html. (Accessed June 29, 2004)
4. Center for Drug Kvalualion and Research. CDER 2002 Report to the Nation, http://www.fda.gov/hcder/reports/rtn/2002/rtn2002.htm. (Accessed Feb 17, 2004)
5. Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nature Rev. 2003;2:695–702.
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献