●Editorial | Kageyama S | 390 |
●Safety information: reporting, dissemination, and analysis | ||
Issues on safety information management in Japan | Kobayashi F,Tamura N | 391-7 |
Handling of safety information during clinical trials with reference to ICH guidance and CIOMS recommendations | E. Stewart Geary | 399-408 |
(trans. by Nakatsuka M,Boyar E, Pharmacovigilance Working Group) | 409-17 | |
The PAC (: Professional assessment of causality on ADR reports) Survey Study on DLST in 71,668 cases in Japan | Shimizu N,Koshikawa S, Nomura T,et al. | 419-26 |
Why are Japanese boys dropping down?: Considerations on the cause of oseltamivir-related abnormal behavior | Saio T | 427-33 |
●The 2nd Kyoto University pharmacoepidemiology symposium | ||
−The role of pharmacoepidemiology in the research and development of new drug− | ||
Organized by Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University,Supervised by: Kawakami K | 435-537 | |
●Proposals and study reports | ||
Where are we now in the race for innovation?−A proposal of three laws for stronger Japan | Fukushima M | 539-44 |
Problems regarding the investigational products supply in J-GCP: To promote the global clinical trials | Ono M | 545-54 |
Coordination report from a post-marketing study carried by a single organization: From the Prevention of Coronary Sclerosis (PCS) study | Uehara Y,Mizuno D, Komatsu M,et al. | 555-70 |
Basis for the conduct of microdosing clinical trials in Japan: Third report Draft guidance for exploratory investigational new drug clinical trials | Sugiyama Y,Mayahara H, Ikeda T,et al. | 571-94 |
Proposal of a Draft Human Research Participants Protection Bill 2007 −The most essential legal basis for bioethical issues: Second report− | Mitsuishi T,Nudeshima J, Kurihara C,et al. | 595-611 |
●Forum | ||
How do we translate "should" and "shall" into Japanese? | Uchida E,Kageyama S, Tsubaki H | 613-4 |
Mitsukoshi Radish Project (MDP), otherwise, Project KFD (Kentucky Fried Data)−Hey! Boys and Girls in Research Lab. How about CRO package service from non-clinical to clinical trial?− | Itoh K | 614-8 |
●Instructions for authors [English] | 619-24 | |
●Editor's note | Nudeshima J | 625 |
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