|
||
●Editorial | Mitsuishi T | 379-80 |
●The 2000 revision to the Declaration of Helsinki and ethics in this era of globalization | ||
1,The 2000 Edinburgh revision to the Declaration of Helsinki | ||
On the Edinburgh revision of the Declaration of Helsinki | Mitsuishi T | 381-95 |
The ethical bases of the ICH-E10 guideline and the revised Declaration of Helsinki | Ono S | 397-407 |
Interview with Robert J. Levine, Peter Lurie and Stephan W Lagakos −Discussion on the Declaration of Helsinki and its background− |
Levine RJ, Lurie P, Lagakos SW | 409-22 |
The ethical issues of HIV/AIDS research in developing countries | Sato K | 423-8 |
2,Patient recruitment and the protection of human subjects | ||
Protection of human subjects in clinical trials using advanced technology −Lessons to be learnt− | Yoshikawa S | 429-35 |
Ethical issues of Japanese recruitment for clinical trials −How do they compare with those of the US ?− | Mano T | 437-40 |
Clinical trial of a disease and My illness−From a Simulated Patinet's viewpoint− | Saeki H | 441-5 |
Basic principles for the protection of the rights of human research subjects | Yokota Y | 447-56 |
3,The pharmaceutical scene in this era of globalization | ||
Discussions on multinational pharmaceutical development and the rational
use of drugs in the North-South context of international health | 457-95 | |
Part 1:Ethnic differences in multinational trials −the cases of South Africa, Republic of Korea, and Japan | Barnes K, Shin S, Uchida E, Tsutani K | 459-70 |
Part 2:Activities of the INRUD and the East Asian pharmaceutical scene | Bimo, Ratanawijitrasin S, Pick WM, Yang B, et al. | 471-8 |
Part 3:Access to drugs in developing countries−the lawsuit in South Africa | Kido O, Hirabayashi F, Misago C, et al. |
479-95 |
4,Yakurou (drug basket) at four levels | ||
Yakurou (drug basket) at four levels−global, country, hospital and prescriber− | Tsutani K | 497-8 |
Selection of drugs for the WHO Model List of Essential Drugs−Viewed
from a member of the WHO Expert Committee on Essential Drugs Secretariat− |
Fukui T | 499-504 |
Number of drugs in Japan from the administrative standpoint of new drug approval and medical reimbursement |
Kubota H | 505-11 |
The current status of the hospital formulary and new drugs adoption
systems in Japan−A survey of 112 hospitals and clinics affiliated with the Japanese Society for Pharmacoepidemiology− |
Shimizu H, Tsutani K, Yoshida h, et al. |
513-20 |
Personal drugs selection and its role in rational treatment | Uchida E | 521-5 |
●Materials | ||
Declaration of Helsinki | World Medical Association | 527-30 |
Choice of control group in clinical trials | Notification from Evaluation and Licensing Division, Pharmceutical and Medical Safety Bureau, Ministry of Health, Labor and Welfare | 531-57 |
The Belmont report | The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (trans. by Tsutani K, Mitsuishi T, Kurihara C) |
559-68 |
●Original | ||
Late Phase II study of Y-23684 on Neurosis −A placebo-controlled comparative randomized double-blind study− | Miura S, Murasaki M, Kudo Y, et al. | 569-93 |
●Instructions for authors [English] | 595-600 | |
●Editor's note | Omori Y | 601 |