IMPACT OF GLOBALIZATION UNDER THE ICH GUIDELINES ON THE CONDUCT OF REPRODUCTIVE TOXICITY STUDIES : REPORT ON CURRENT STATUS IN JAPAN, EUROPE AND THE US BY QUESTIONNAIRE SURVEY

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概要

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• We surveyed interpretation of the ICH guidelines concerning reproductive toxicology. Valid responses were obtained from Japan (JPN), Europe (EUR) and the US. The results obtained were compared to those at the time of a previous survey targeted at JPN facilities in 1995-1996 as well as compared among all three regions. Compared to the previous survey in Japan, the number of facilities performing toxicokinetics (TK) in rats has slightly increased. This result was considered to represent changes of attitude toward TK in reproductive toxicity studies. Differences in interpretation of the guidelines between JPN, EUR and the US were widely seen. Clear differences were noted in sperm examinations, postnatal tests, fetal examinations, some examinations for Fl animals after culling and TK. Researchers in the West seemed to be interpreting the ICH guidelines more flexibly from the scientific point of view. JPN researchers appeared to interpret the guidelines, including notes, as rigid requirements. Most of the parts which produced different interpretations were the notes in the guidelines. The force of mention in the notes should be defined in the future. In addition, there were doubts about some parts, including notes, which had been found to have become unsuitable for the implementation of studies because of scientific progress or from long experience in using the guidelines. Therefore, updates of the guidelines may be needed in the future as well as the remedy of interpretation by JPN researchers. In JPN, the number of reproductive toxicity studies has decreased. The scanty experience in JPN therefore raises apprehension of appropriate selection and stagnating development of methodology, and might hinder the maintenance of the guidelines. In the future, the cooperation of CROs as well as global collaboration will be essential not only to scientific developments of reproductive toxicology but also updates of the guidelines.

• 日本トキシコロジー学会の論文
• 2004-08-30

著者

• Hirano Fumiya

  Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (jpma):research & D

• Numa Toshiaki

  Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (jpma):toxicology Team

• Endo Y

  Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (jpma):clinical Safety

• Nishigaki K

  Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (jpma):fuji Research La

• Matsuzawa T

  Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (jpma)

• MINESHIMA Hiroshi

  Drug Evaluation Committee, the Japan Pharmaceutical Manufacturers Association (JPMA)

• ENDO Yoshihiko

  Drug Evaluation Committee, the Japan Pharmaceutical Manufacturers Association (JPMA)

• OGASAWARA Hiroyuki

  Drug Evaluation Committee, the Japan Pharmaceutical Manufacturers Association (JPMA)

• NISHIGAKI Keiji

  Drug Evaluation Committee, the Japan Pharmaceutical Manufacturers Association (JPMA)

• MATSUZAWA Toshiaki

  Drug Evaluation Committee, the Japan Pharmaceutical Manufacturers Association (JPMA)

• Mineshima H

  Drug Safety Res. Laboratories (kakamigahara) Eisai Co. Ltd.

• Ogasawara Hiroyuki

  Drug Evaluation Committee The Japan Pharmaceutical Manufacturers Association (jpma):medical Research

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