关于生物技术衍生药物非临床研究安全性评估的“需考虑要点”（英文译文）

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

作者信息

Nakazawa Takahiro, Kai Shuichi, Kawai Mutsufumi, Maki Eiji, Sagami Fumio, Onodera Hiroshi, Kitajima Satoshi, Inoue Tohru

机构信息

Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.

出版信息

J Toxicol Sci. 2004 Dec;29(5):497-504. doi: 10.2131/jts.29.497.

DOI:10.2131/jts.29.497

PMID:15729005

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.

摘要

监管科学家和行业科学家合作，于2002年发表了一份关于生物技术衍生药物非临床研究安全性评估的“需考虑要点”文件（药物非临床研究组，2002年）。合作团队旨在阐明对ICH-S6指南的解读，并进一步分享日本近期在这方面的做法。然而，该文件是用日语撰写的。因此，我们在此分享该文件的英文译文，以便非日语母语者能够正确理解其内容。