Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan
2005; Wiley; Volume: 78; Issue: 2 Linguagem: Inglês
10.1016/j.clpt.2005.04.001
ISSN1532-6535
AutoresYoshiaki Uyama, Toshihiko Shibata, Nao Nagai, Hideki Hanaoka, S. Toyoshima, Keiji Mori,
Tópico(s)Drug Transport and Resistance Mechanisms
ResumoClinical Pharmacology & TherapeuticsVolume 78, Issue 2 p. 102-113 Commentary Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan Yoshiaki Uyama PhD, Corresponding Author Yoshiaki Uyama PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, Chiba Yoshiaki Uyama, PhD, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg, 3–3–2 Kasumigaseki, Chiyodaku, Tokyo 100–0013, Japan. E-mail: [email protected]Search for more papers by this authorTaro Shibata MS, Taro Shibata MS Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorNaomi Nagai PhD, Naomi Nagai PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorHideki Hanaoka MD, PhD, Hideki Hanaoka MD, PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorSatoshi Toyoshima PhD, Satoshi Toyoshima PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorKazuhiko Mori MS, Kazuhiko Mori MS Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this author Yoshiaki Uyama PhD, Corresponding Author Yoshiaki Uyama PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, Chiba Yoshiaki Uyama, PhD, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg, 3–3–2 Kasumigaseki, Chiyodaku, Tokyo 100–0013, Japan. E-mail: [email protected]Search for more papers by this authorTaro Shibata MS, Taro Shibata MS Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorNaomi Nagai PhD, Naomi Nagai PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorHideki Hanaoka MD, PhD, Hideki Hanaoka MD, PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorSatoshi Toyoshima PhD, Satoshi Toyoshima PhD Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this authorKazuhiko Mori MS, Kazuhiko Mori MS Pharmaceuticals and Medical Devices Agency and Statistics and Cancer Control Division, National Cancer Center, Tokyo Department of Clinical Research, Chiba University Hospital, ChibaSearch for more papers by this author First published: 11 August 2005 https://doi.org/10.1016/j.clpt.2005.04.001Citations: 25 Before establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) in April 2004, all authors worked for the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) of the National Institute of Health Sciences. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat References 1 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline: Ethnic Factors in the Acceptability of Foreign Clinical Data. E5, step 4. Geneva, Switzerland, 1998. Available from: URL:http://www.ich.org/MediaServer.jser?@_ID=481&_MODE=GLB Accessed April 5, 2005. 2Naito, C. (2000). 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Notification No. 739 (Kyokuchou-tsuuchi) and No. 672 (Kachou-tsuuchi). August 11 Pharmaceuticals Medical Safety Bureau, Ministry of Health, Labour and Welfare: Japan. 8Lin, Y. L., Chern, H. D. and Chu, M. L. (2003). Taiwan's experience with the assessment of acceptability of the extrapolation of foreign clinical data for registration purposes. Drug Inf J 37: 143–145. 9Bjornsson, T. D., Wagner, J. A., Donahue, S. R., Harper, D., Karim, A. and Khouri, M. S., et al. (2003). A review and assessment of potential source of ethnic differences in drug responsiveness. Clin Pharmacol 43: 943–967. 10Kim, K., Johnson, J. A. and Derendorf, H. (2004). Differences in drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms. J Clin Pharmacol 44: 1083–1105. 11Marzolini, C., Paus, E., Buclin, T. and Kim, R. B. (2004). Polymorphisms in human MDR1 (P-glycoprotein): Recent advances and clinical relevance. Clin Pharmacol Ther 75: 13–33. 12Shimizu, T., Ochiai, H., Asell, F., Yokono, Y., Kikuchi, Y. and Nitta, M., et al. (2003). Bioinformatics research on inter-racial difference in drug metabolism II. Analysis on relationship between enzyme activities of CYP2D6 and CYP2C19 and their relevant genotypes. Drug Metab Pharmacokinet 18: 71–78. 13McCarthy, L. C., Davies, K. J. and Campbell, D. A. (2002). Pharmacogenetics in diverse ethnic populations-implications for drug discovery and development. Pharmacogenomics 3: 493–506. Citing Literature Volume78, Issue2August 2005Pages 102-113 ReferencesRelatedInformation
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