"POINTS TO CONSIDER" REGARDING SAFETY ASSESSMENT OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS IN NON-CLINICAL STUDIES (ENGLISH TRANSLATION)
スポンサーリンク
概要
- 論文の詳細を見る
Regulatory and industrial scientists collaborated to publish a "points to consider" document regarding the safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies in 2002 (Pharmaceutical Non-clinical Investigation Group, 2002) The collaboration team intended to clarify the interpretation of ICH-S6 guideline and furthermore share recent Japanese practices on this matter However, the document was written in Japanese Thus, we share here an English translation of the document so that non-native Japanese correctly understand the contents
- 日本トキシコロジー学会の論文
- 2004-12-27
著者
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KAI Shuichi
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures A
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SAGAMI Fumio
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufactures A
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Kai Shuichi
ブリストルマイヤーズスクイブ
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Kai Shuichi
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
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Kai Shuichi
東京都健康安全研究センター
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Kai Shuichi
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
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Sagami Fumio
第一三共安全性研究所
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Sagami Fumio
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
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Sagami Fumio
Drug Safety Research Laboratories Eisai Co. Ltd.
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Sagami Fumio
Subcommittee Of Non-clinical Evaluation Drug Evaluation Committee Japan Pharmaceutical Manufacturers
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Sagami Fumio
Department Of Drug Safety Research Eisai Kawashima Research Laboratories Eisai Co. Ltd.
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Kitajima Satoshi
Department Of Environmental Health And Toxicology Tokyo Metropolitan Institute Of Public Health
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Satoh Kanako
東京都健康安全研究センター 環境保健部
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Satoh Kanako
Department Of Environmental Health And Toxicology Tokyo Metropolitan Institute Of Public Health
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Shirao Kuniaki
Gastrointestinal Oncology Division National Cancer Center Hospital
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Sai Kimie
Divislon Of Toxicology National Institute Of Health Sciences
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Sai-kato Kimie
Division Of Toxicology
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Onodera Hiroshi
東京都健康安全研究センター
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小野寺 博志
Division Of Pathology National Institute Of Health Sciences
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Onodera Hiroshi
Pharmaceuticals And Medical Devices Agency
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Sekita Kiyoshi
Division Of Cellular & Molecular Toxicology National Institute Of Health Sciences
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KITAJIMA Satoshi
Division of Cellular and Molecular Toxicology, BSRC, National Institute of Health Sciences
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Inoue Tohru
Biological Safety Research Center, National Institute of Health Sciences
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Shinoda Kazutoshi
Pharmaceuticals and Medical Devices Agency
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NAKAZAWA Takahiro
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers
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KAWAI Mutsufumi
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers
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MAKI Eiji
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers
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Maki E
Japan Pharmaceutical Manufacturers Assoc. Tokyo Jpn
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Kawai Mutsufumi
Non-clinical Evaluation Subcommittee Drug Evaluation Committee Japan Pharmaceutical Manufacturers As
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Inoue Tohru
Biological Safety Res. Center National Inst. Of Health Sciences
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Sakemi Kazue
Division Of Pharmacology And Biological Safety Research Center National Institute Of Health Sciences
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Nakazawa Takahiro
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Non-clinical Evaluation Sub
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Onodera H
Pharmaceuticals And Medical Devices Agency
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Kurokawa Misao
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Non-clinical Evaluation Sub
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Kitajima S
Department Of Environmental Health And Toxicology Tokyo Metropolitan Institute Of Public Health
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Kitajima S
Division Of Cellular & Molecular Toxicology Biological Safety Research Center National Institute
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Kitajima Satoshi
Division Of Cellular And Molecular Toxicology Biological Safety Research Center National Institute O
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Onodera Hiroshi
Dvision Of Pathology Biological Safety Research Center National Institute Of Health Sciences
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Inoue Tohru
Biological Safety Research Center National Institute Of Health Sciences
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Onodera Hiroshi
Pharmaceutical And Medical Devices Agency
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