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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.

出版信息

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

PMID:9737398
Abstract
摘要

相似文献

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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
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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。
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