JCO Early Release, published online ahead of print Nov 2 2009
Journal of Clinical Oncology, 10.1200/JCO.2009.23.9020
Critical Review of the Determination Process by the Japanese Reviewing Authority in Approving the Additional Efficacy of Fludarabine Phosphate
Hiroto Narimatsu1, Giichiro Oiso2, Shunsuke Ono3, and Masahiro Kami1
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