●Editorial | Ohashi K | 378 |
●The international meeting for promotion of global clinical development in Tokyo What is the true endpoint of global clinical trials and how do we manage? | ||
Organized by: Clinical Trial Support Center, Showa University Hospital The Head of the Executive Committee : Uchida E | 381-471 | |
Opening remarks | Uchida E | 383 |
Original idea of ICH and international simultaneous clinical trials | Kurokawa T | 384-99 |
A comparison of pharmacokinetic data - Chinese and foreigners | Cui Y | 400-7 |
Different Dosing for drugs approved in Japan, the United States, and Europe | Nakanishi T,Sato J | 408-15 |
Exploring international differences in approved dose | Arnold F,Kusama M, Ono S,Sugiyama Y | 416-23 |
The problems concerning the clinical trial of an overseas initiative protocol- From a doctor’s viewpoint | Kobayashi Y,Watanabe N,Kawamura M,et al. | 424-34 |
Physicians must be trained for the promotion of global clinical trials | Ueda S | 435-45 |
Global simultaneous development - From an industry point of view | Inazu M,Tanaka N | 446-54 |
Recent changes in the General Clinical Research Center (GCRC) | Uemura N | 455-6 |
Panel discussion: To become a real partner in the world for global clinical trials | 457-69 | |
Closing remarks | Nomoto M | 470 |
●Articles | ||
Draft guidance for developing radiolabeled imaging drugs | Yano T,Inoue T,Ito K,et al. | 473-96 |
The trend concerning microdosing and PET molecular imaging clinical trials in United States, United Kingdom, and Sweden (NEDO Microdose-PJ) | Kurihara C,Inano A,Fukushima Y,Ito H | 497-515 |
Discovery of the “seeding trial” and misgivings about PROBE studies | Saio T | 517-22 |
●Article and translation | ||
The ICMJE Uniform Disclosure Form for Potential Conflicts of Interest: Its background and remaining problems | Saio T,Kurihara C | 523-7 |
Uniform Format for Disclosure of Competing Interests in ICMJE journals Drazen JM,Van Der Weyden MB,Sahni P,et al. ※ICMJE Uniform Requirements is revised. You can see revised edition translation in Vol.38, No. 2. | (trans. by Fukushima Y,Saio T) | 529-38 |
●Manual for diagnosis of Adverse Drug Event | Shimizu N | 539-97 |
●Instructions for authors [Japanese] & [English] | 599-604 | |
●Editor's note | Kurokawa T | 605 |