"Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation).
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.
Nakazawa
Takahiro
T
Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
Kai
Shuichi
S
Kawai
Mutsufumi
M
Maki
Eiji
E
Sagami
Fumio
F
Onodera
Hiroshi
H
Kitajima
Satoshi
S
Inoue
Tohru
T
D000818:Animals; D001688:Biological Products / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D018675:Toxicity Tests / Q000379:methods
D001688:Biological Products