Vol.36, Suppl XXVI Jul. 2009 Clinical science : Principles and practice - Science, law and humanity -
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| Contents | |
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| ●Editorial | Fukushima M | 5-7 |
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| ●Clinical science : Principles and practice - Science, law and humanity- | Fukushima M | 9-48 |
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●The 7th Translational Research Workshop
Organized by : Foundation for Biomedical Research and Innovation | | 49-172 |
| Departure of Hokkaido Organization for Translational Research (HTR) | Shirato H | 50-9 |
Challenge to translational research in Tohoku University
─ Innovation of new biomedical engineering center─ | Nishida K | 60-8 |
Translational Research Advancement Center and its execution of TR
in the University of Tokyo | Yamashita N | 69-73 |
| Recent progress for the translational research projects in Nagoya University | Wakabayashi T | 74-81 |
The challenging in the end term of investigator-initiated clinical trials
in Kyoto University Hospital | Ito T | 82-6 |
| We are the supporters for translational researchers | Matsuyama A | 87-95 |
| Present status of translational research at Kyushu University | Nakanishi Y | 96-106 |
Present and future prospects of the support for the translational research
in the Foundation for Biomedical Research and Innovation | Koibuchi Y | 107-12 |
Investigator-led clinical trial to standardize the vascular regeneration
therapy
for clitical limb ischemia | Kinoshita M | 113-9 |
| Future trend and development of peripheral arterial regeneration clinical
trials | Hoshino J | 120-31 |
| A cell therapy for stroke | Honmou O | 132-9 |
| A new treatment for spinal cord injury using bone marrow stromal cells | Suzuki Y | 140-5 |
| Regenerative medicine for cornea | Nishida K | 146-58 |
Developing the Translational Research Informatics Center, the first academic
clinical trial datacenter ─ Brief history of the initial five years | Fukushima M | 159-72 |
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| ●Original | | |
Current status of Japanese universities' management of conflict of interest
in clinical research ─ Survey of conflict of interest policies and rules ─ | Saotome C，Yoshida K, Teranishi Y | 173-82 |
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| ●Translations and article | | |
Guidance for Industry Regulation of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide
U.S. Department of Health and Human Services,
Food and Drug Administration (FDA),
Center for Biologics Evaluation and Research (CBER) | trans. by Nishikawa A, Murayama T, Maekawa T |
183-96 |
Guidance for Industry Eligibility Determination for Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
U.S. Department of Health and Human Services,
Food and Drug Administration (FDA),
Center for Biologics Evaluation and Research (CBER) | trans. by Nishikawa A, Murayama T, Maekawa T | 197-256 |
Guidance for Industry CGMP for Phase 1 Investigational Drugs
U.S. Department of Health and Human Services,
Food and Drug Administration (FDA),
Center for Drug Evaluation and Research (CDER), et al. | trans. by Nishikawa A, Murayama T, Maekawa T | 257-73 |
Stepwise approach complying with CGMP regulation is indispensable
for the progressof translational research in academia | Maekawa T | 274 |
Methodological considerations for using Progression-Free Survival (PFS)
as primary endpoint in confirmatory trials for registration
European Medicines Agency (EMEA),
Committee for Medicinal Products for Human Use (CHNP) | trans. by Nishikawa A, Teramukai S | 275-8 |
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| ●Instructions for authors [Japanese] & [English] | | 279-84 |