title: "Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation).
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.
authors.affiliation: Non-clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Nakazawa
authors.forename: Shuichi
authors.initials: S
authors.lastname: Kai
authors.forename: Mutsufumi
authors.initials: M
authors.lastname: Kawai
authors.forename: Eiji
authors.initials: E
authors.lastname: Maki
authors.forename: Fumio
authors.initials: F
authors.lastname: Sagami
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Onodera
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kitajima
authors.forename: Tohru
authors.initials: T
authors.lastname: Inoue
mesh_terms: 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
chemical_list: D001688:Biological Products