i POINTS TO CONSIDERi REGARDING SAFETY ASSESSMENT OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS IN NON-CLINICAL STUDIES (ENGLISH TRANSLATION

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  • NAKAZAWA Takahiro
    Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
  • KAI Shuichi
    Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
  • KAWAI Mutsufumi
    Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
  • MAKI Eiji
    Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
  • SAGAMI Fumio
    Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
  • ONODERA Hiroshi
    Pharmaceuticals and Medical Devices Agency
  • KITAJIMA Satoshi
    Division of Cellular & Molecular Toxicology, Biological Safety Research Center, National Institute of Health Sciences
  • INOUE Tohru
    Biological Safety Research Center, National Institute of Health Sciences

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  • "Points to consider"regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation)

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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.<br>

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