●Editorial | Ohashi K | 434 |
●J-CLIPNET−Bases for early phase global clinical development | ||
●Reports | ||
Early phase global clinical trial's infrastructure development: A report of the activity of J-CLIPNET | Ohashi K | 435-50 |
Report of visiting program to Europe by J-CLIPNET | Ohashi K, Uchida E, Kumagai Y, et al. | 451-85 |
Explanatory review on the documents for improvement of phase 1 clinical trials, published in the United Kingdom and in the European Union, translated into Japanese in this issue | Ohashi K, Kurihara C, Saio T | 487-97 |
●Translations | ||
Translated documents concerning phase 1 clinical trials by J-CLIPNET Medicines and Healthcare products Regulatory Agency(MHRA), European Medicines Agency(EMEA), The Association of the British Pharmaceutical Industry(ABPI) | (trans. by Ohashi K, Uchida E, Umemura K, et al.) | 499-592 |
●Articles | ||
Survey results of clinical data management education in medical institutions in Japan | Kanda N, Uno H, Aotani E, Takahashi F | 593-607 |
Survey for utilization of Electronic Data Capture in clinical trials conducted by pharmaceutical companies in Japan | Matsuba H, Yamamoto K, Teramukai S, Fukushima M | 609-24 |
Paradoxical medicines:long-term administration of bisphosphonates evokes clinical bone-fracture | Saio T | 625-32 |
●Proposals | ||
Draft guidance for exploratory investigational new drug clinical trials: Except microdosing | Sugiyama Y, Mayahara H, Ikeda T, et al. | 633-50 |
Meaning and basis for the conduct of microdose clinical trials on peptides and proteins in Japan | Yano T, Sugiyama Y, Kato M, et al. | 651-65 |
Actual status of GCP investigations and future perspective −For solution of "over quality issue": Focused on comparation of Japan, US, EU regulations− | Watanabe H, Kageyama S, Kurihara C | 667-81 |
An opinion to the Expert Committee on the Ethical Guideline for Clinical Research(1):An explanatory speech on the public comment (September 13, 2007) | Mitsuishi T | 683-8 |
An opinion to the Expert Committee on the Ethical Guideline for Clinical Research(2):Essential issues for the Ethical Guideline for Clinical Research:i.e. history of the Declaration of Helsinki, ethics committee, substituted judgment and research results publication(February 13, 2008) | Mitsuishi T | 689-98 |
●Forum | ||
Why do we not think about an academic discount for microdosing study? | Itoh K | 699-702 |
Unmet medical demand:research and development of innovative medicines | Saio T | 703-4 |
●Instructions for authors[Japanese]&[English] | 705-10 | |
●Editor's note | Fukushima M | 711 |