| ●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| Draft guidance for exploratory investigational new drug clinical trials： Except microdosing | Sugiyama Y, Mayahara H, Ikeda T, et al.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 |