Vol.28, No.3, Jun. 2001  The 2000 revision to the Declaration of Helsinki
and ethics in this era of globalization
   
contents
 
EditorialMitsuishi T379-80
 
●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 HelsinkiMitsuishi T381-95
    The ethical bases of the ICH-E10 guideline and the revised Declaration of HelsinkiOno S397-407
    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 S429-35
    Ethical issues of Japanese recruitment for clinical trials
    −How do they compare with those of the US ?−
Mano T437-40
    Clinical trial of a disease and My illness−From a Simulated Patinet's viewpoint−Saeki H441-5
    Basic principles for the protection of the rights of human research subjectsYokota Y447-56
 
  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 sceneBimo, 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 K497-8
    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 HelsinkiWorld Medical Association527-30
    Choice of control group in clinical trialsNotification 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 noteOmori Y601


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