The Journal of Toxicological Sciences
Online ISSN : 1880-3989
Print ISSN : 0388-1350
ISSN-L : 0388-1350
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"POINTS TO CONSIDER" REGARDING SAFETY ASSESSMENT OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS IN NON-CLINICAL STUDIES (ENGLISH TRANSLATION)
Takahiro NAKAZAWAShuichi KAIMutsufumi KAWAIEiji MAKIFumio SAGAMIHiroshi ONODERASatoshi KITAJIMATohru INOUE
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2004 Volume 29 Issue 5 Pages 497-504

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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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© 2004 The Japanese Society of Toxicology
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