Critical Review of the Determination Process by the Japanese Reviewing Authority in Approving the Additional Efficacy of Fludarabine Phosphate-Reference-Cited by-同舟云学术

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Critical Review of the Determination Process by the Japanese Reviewing Authority in Approving the Additional Efficacy of Fludarabine Phosphate

Published:2009-12-01 Issue:34 Volume:27 Page:e236-e238
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Narimatsu Hiroto¹,Oiso Giichiro²,Ono Shunsuke³,Kami Masahiro¹

Affiliation:

1. Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan

2. Cancer Control Programs Administration Division, Center for Cancer, Control and Information Services, National Cancer Center, Tokyo, Japan

3. Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Link

http://ascopubs.org/doi/pdfdirect/10.1200/JCO.2009.23.9020

Reference3 articles.

1. Off-label Prescribing Among Office-Based Physicians

2. Reduced-Intensity Regimens in Allogeneic Hematopoietic Stem Cell Transplantation for Hemoglobinopathies

3. Prospective phase II trial to evaluate the complications and kinetics of chimerism induction following allogeneic hematopoietic stem cell transplantation with fludarabine and busulfan

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1. Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects;Investigational New Drugs;2016-08-19

2. Approving molecularly targeted drugs: different approval processes for cytotoxic agents;International Journal of Clinical Oncology;2016-04-22

3. Critical review of ‘Public domain application’: a flexible drug approval system in Japan;Annals of Oncology;2013-05

4. Resequencing of the vascular endothelial growth factor promoter reveals haplotype structure and functional diversity;Angiogenesis;2010-06-16

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