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sophieyjing

银虫 (小有名气)

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虫号: 1610730
注册: 2012-02-10
性别: MM
专业: 血型与输血

[求助] 急求FDA生物类似药法规的中文译文~谢谢分享~

求以下FDA生物类似药注册法规中文译文，谢谢分享~提供任意一篇即可领取赏金~

Sections 7001-7003 (Biologics Price Competition and Innovation Act of 2009) of the Patient Protection and Affordable Care Act (Public Law No. 111-148)

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product-Draft

Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product

Biosimilars Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Biosimilars Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009Draft Guidance

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