| ●Editorial | Fukushima M | 475 |
| ●Article | ||
| Translational research in Japan―A proposal to amend the Pharmaceutical Affairs Law,or of enforcement of the Research Participants Protection Act― | Fukushima M | 477-86 |
| ●Basis of translational research Academia-oriented clinical trials and new drug and medical technology development | ||
| ・Symposium | ||
| Franco-Japanese Translational Research Initiative (1st) Sponsor: INSERM (Institut national de la santé et de la recherche médicale) & St. Louis Hospital (France), Kyoto University Hospital Translational Research Center (Japan) | 487-581 | |
| ・Material | ||
| Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research（CDER） | (trans. by Nishikawa A, Murayama T, Kasai Y, et al.) | 583-99 |
| Exploratory IND Studies: The Perspective from Academia | Murayama T | 600-2 |
| Guidance for Industry INDs ─Approaches to Complying with CGMP During Phase 1 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) | (trans. by Ezoe S, Murayama T, Nishikawa A, et al.) | 603-24 |
| CGMP regulation for translational research | Maekawa T | 625-7 |
| ・Interview | ||
| Standard for Cell Processing Center and FDA's Current Good Manufacturing Practice (CGMP) during Phase 1 | Maekawa T | 629-40 |
| Proposal for setting guidelines of the cell processing facility and sharing principles of Current Good Manufacturing Practice (GCMP) in academia | Tahara H | 641-8 |
| ・Articles | ||
| Basis for the conduct of microdose clinical trials in Japan： A proposal toward formulation of guidelines | Sugiyama Y, Kurihara C, Mayahara H, et al. | 649-77 |
| Safety of microdose clinical trials | Mayahara H | 679-94 |
| The French research participants protection regulations in 2006 (1) The Research Review Committee | Nudeshima J | 695-700 |
| ・Short communication | ||
| Metabolic syndrome as disease mongering： Deconstructing the concept of the life style related disease | Nango E, Saio T | 701-16 |
| ・Forum | ||
| Let's challenge drug development with innovative ideas | Yano T | 717-9 |
| Microdosing─Getting back the compound to the research scientist! ─ | Itoh K | 719-21 |
| Who will put a bell on the cat? ─Human Radioisotope Study and Association for Promoting Drug Development (APDD) ─ | Ikeda T | 721-4 |
| ●Yoshihito Omori (1922-2006) | Kageyama S | 725-6 |
| ●Instructions for authors [English] | 727-32 | |
| ●Editor's note | Mitsuishi T | 733-4 |