FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product"
Titel:
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product"
Internet:
Herkunft/Verlag:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
Dokumentenart:
Guidance for Industy
Inhalt:
This document comprises information about analytical factors and the importance of extensive analytical, physico-chemical and biological characterisation of a Biosimilar. These factors are unalienable to demonstrate highly similarity to a reference product.