FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing - RegulatoryAffairs版 - 未名存档

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RegulatoryAffairs版 - FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing

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发帖数: 25265

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http://www.raps.org/regulatoryDetail.aspx?id=18611
FDA's site for Biosimilars:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm

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