生物技术产品的质量：源自人或动物细胞系的生物技术产品的病毒安全性评估。国际协调会议三方协调指南。 - Suppr

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超能文献

Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline.

出版信息

Dev Biol Stand. 1998;93:177-201.

PMID:9737396

Abstract

摘要

相似文献

Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. ICH Harmonised Tripartite Guideline.生物技术产品的质量：源自人或动物细胞系的生物技术产品的病毒安全性评估。国际协调会议三方协调指南。

Dev Biol Stand. 1998;93:177-201.

Quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products. ICH Harmonised Tripartite Guideline.生物技术产品质量：用于生产重组DNA衍生蛋白产品的细胞系中表达构建体的分析。国际人用药品注册技术协调会三方协调指导原则

Dev Biol Stand. 1998;93:205-8.

Quality of biotechnological products: derivation and characterisation of cell substrates used for production of biotechnological/biological products. ICH Harmonised Tripartite Guideline.生物技术产品质量：用于生产生物技术/生物制品的细胞基质的来源与特性。国际协调会议三方协调指南。

Dev Biol Stand. 1998;93:223-34.

Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.生物技术产品的质量：生物技术/生物制品的稳定性试验。国际人用药品注册技术协调会《新药原料药和制剂稳定性试验指导原则》三方协调指南附件

Dev Biol Stand. 1998;93:211-9.

International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice.国际协调会议；关于源自人或动物细胞系的生物技术产品病毒安全性评估的指南；可获取性——美国食品药品监督管理局。通知。

Fed Regist. 1998 Sep 24;63(185):51074-84.

WHO requirements for the use of animal cells as in vitro substrates for the production of biologicals (requirements for biological substances No 50).世界卫生组织关于使用动物细胞作为生物制品生产的体外基质的要求（生物制品要求第50号）。

Dev Biol Stand. 1998;93:141-71.

Safety of biological products prepared from mammalian cell culture. In-process testing for viral agents.源自哺乳动物细胞培养物的生物制品的安全性。病毒因子的过程检测。

Dev Biol Stand. 1998;93:130-1.

Dev Biol Stand. 1996;88:15-8.

Safety of biological products prepared from mammalian cell culture. Detecting viruses in cell banks.源自哺乳动物细胞培养的生物制品的安全性。检测细胞库中的病毒。

Dev Biol Stand. 1998;93:129.

International Conference on Harmonisation; guidance on quality of biotechnological/biological products: derivation and characterization of cell substrates used for production of biotechnological/biological products; availability. Notice. Food and Drug Administration, HHS.国际协调会议；生物技术/生物制品质量指南：用于生产生物技术/生物制品的细胞基质的来源与特性；可获取性。通知。美国卫生与公众服务部食品药品监督管理局

Fed Regist. 1998 Sep 21;63(182):50244-9.

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