Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions : correlation analysis of 142 approved drugs in Japan
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概要
- 論文の詳細を見る
- 2013-08-01
著者
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OHKURA Takako
Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures A
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Nakamura Kazuichi
Non-clinical Evaluation Expert Committee Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association (jpma)
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NAGAYAMA Takashi
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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TAMAKI Chihiro
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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HASHIBA Masamichi
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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FUJIYOSHI Masato
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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HIZUE Masanori
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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KODAIRA Hiroshi
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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NISHIDA Minoru
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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SUZUKI Kazuhiko
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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TAKASHIMA Yoshiharu
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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OGINO Yamato
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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YASUGI Daisaku
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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YONETA Yasuo
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
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HISADA Shigeru
Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
関連論文
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- O-09 No-Observed Adverse Effect Level(NOAEL) : Judging Criteria and Purpose in Safety Assessment of Pharmaceuticals(STATISTICAL AND TEST METHODS/GENERAL TOXICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 31st Annual Meeting)
- O-08 Questionnaire Survey on No Observed Adverse Effect Level(2) : Regulatory Comments and Company(STATISTICAL AND TEST METHODS/GENERAL TOXICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 31st Annual Meeting)
- O-07 Questionnaire Survey on No Observed Adverse Effect Level(1) : Concept of NOAEL(STATISTICAL AND TEST METHODS/GENERAL TOXICITY)(GENERAL SESSION BY ORAL PRESENTATION)(Proceedings of the 31st Annual Meeting)
- Perspectives on non-clinical safety evaluation of drug metabolites through the JSOT workshop
- Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions : correlation analysis of 142 approved drugs in Japan