"POINTS TO CONSIDER" REGARDING SAFETY ASSESSMENT OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS IN NON-CLINICAL STUDIES (ENGLISH TRANSLATION)

Takahiro NAKAZAWA; Shuichi KAI; Mutsufumi KAWAI; Eiji MAKI; Fumio SAGAMI; Hiroshi ONODERA; Satoshi KITAJIMA; Tohru INOUE

doi:10.2131/jts.29.497

Expository comment

"POINTS TO CONSIDER" REGARDING SAFETY ASSESSMENT OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS IN NON-CLINICAL STUDIES (ENGLISH TRANSLATION)

Takahiro NAKAZAWA, Shuichi KAI, Mutsufumi KAWAI, Eiji MAKI, Fumio SAGAMI, Hiroshi ONODERA, Satoshi KITAJIMA, Tohru INOUE

Author information

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

Keywords: English translation, Points to consider, Non-clinical, Biotechnology-derived pharmaceuticals, ICH-S6 guideline

JOURNAL FREE ACCESS

2004 Volume 29 Issue 5 Pages 497-504

DOI https://doi.org/10.2131/jts.29.497

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Abstract

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.

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