药质量控制研究和质量标准制订之漫谈

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药质量控制研究和质量标准制订之漫谈
General R &D Process
The Roles of Structure Analysis Group in drug development
Phase III
Launch
Post launch
Drug Discovery
      PC & Ph I
PD
      Ph II
Support Toxicology and other activitiesCofA for Tox. Lot potential impuritiesSupport preformulation
Support IND & CTAA Full CofA preliminary reference standardIND Proof of Structure Synthetic impuritiesPotential degradation productRelease testingSupport formulation
Support NDAQualify Primary Reference Standard NDA proof of Str ...

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关键词：质量标准 质量控制 Formulation Preliminary Development