Art

J-GLOBAL ID：201302285362100789   Reference number：13A1929112

Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: correlation analysis of 142 approved drugs in Japan

臨床医薬品副作用を予測するための非臨床安全性評価の可能性と限界 日本で承認された142の医薬品の相関分析

Author (29)： TAMAKI Chihiro (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  TAMAKI Chihiro (Preclinical, Japan Regulatory Affairs, Drug Dev., Eli Lilly Japan K.K.) ,  NAGAYAMA Takashi (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  NAGAYAMA Takashi (Non-Clinical Dev., UCB Japan Co., Ltd.) ,  HASHIBA Masamichi (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  HASHIBA Masamichi (Dev. Res., Mochida Pharmaceutical Co., Ltd.) ,  FUJIYOSHI Masato (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  HIZUE Masanori (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  HIZUE Masanori (DSRD-Tokyo, Pfizer Japan Inc.) ,  KODAIRA Hiroshi (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  KODAIRA Hiroshi (Dev. Planning and Coordination, Pharmaceutical Res. & Dev., Yakult Honsha Co., Ltd.) ,  NISHIDA Minoru (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  NISHIDA Minoru (Res. & Dev. Center, Fuso Pharmaceutical Industries, Ltd.) ,  SUZUKI Kazuhiko (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  SUZUKI Kazuhiko (Translational Sciences, Novartis Pharma K.K.) ,  TAKASHIMA Yoshiharu (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  TAKASHIMA Yoshiharu (Preclinical Experts, Regulatory Affairs, Product Dev. Dep., Bayer Yakuhin, Ltd.) ,  OGINO Yamato (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  OGINO Yamato (Drug Res. Dep., Toa Eiyo Ltd.) ,  YASUGI Daisaku (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  YASUGI Daisaku (Res. & Dev. Center, Fuso Pharmaceutical Industries, Ltd.) ,  YONETA Yasuo (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  YONETA Yasuo (Pharmacokinetics and Safety Res. Dep., Kaken Pharmaceutical Co., Ltd.) ,  HISADA Shigeru (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  HISADA Shigeru (Developmental Res. Center, ASKA Pharmaceutical Co., Ltd.) ,  OHKURA Takako (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  OHKURA Takako (Dep. of Clinical Dev., Maruishi Pharmaceutical Co., Ltd.) ,  NAKAMURA Kazuichi (Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical ...) ,  NAKAMURA Kazuichi (Global Regulatory Affairs Dep., Shionogi & Co., Ltd.)
Material： Journal of Toxicological Sciences  (日本毒性学会学術年会プログラム・要旨集)
Volume： 38  Issue： 4  Page： 581-598 (J-STAGE)  Publication year： 2013 
JST Material Number： Z0265B  ISSN： 0388-1350  Document type： Article
Article type： 原著論文  Country of issue： Japan (JPN)  Language： ENGLISH (EN)

Thesaurus term： *safety evaluation ,...
Semi thesaurus term： *Drug Toxicity

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JST classification (2)： Pharmacology in general  (GW01000B) ,  Toxicity of chemical substances in general  (GZ02010C)

Reference (33)：

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• BETTON, G. A critical review of the optimum duration of chronic rodent testing for the determination of non-tumourigenic toxic potential : a report by the BTS Working Party on Duration of Toxicity Testing. Hum. Exp. Toxicol. 1994, 13, 221-232
• Department of Health. Expert Group on Phase One Clinical Trials : Final report. http://webarchive.nationalarchives.gov.uk/20130107105354/. 2006
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• EMA. Reflection paper of non-clinical evaluation of drug-induced liver injury (DILI). EMEA/CHMP/SWP/150115/2006. 2010

Terms in the title (10)： 臨床 ,  医薬品副作用 ,  予測 ,  安全性評価 ,  可能性 ,  限界 ,  日本 ,  承認 ,  医薬品 ,  相関分析