Points to consider for assessors - New factor VIII and factor IX products: potency determination for labelling and assays for testing post-infusion samples - Scientific guideline
HumanProduct informationScientific guidelines
This document has three objectives:
These points apply to all new factor VIII and factor IX products, i.e. products not previously registered in the EU including plasma-derived, recombinant and modified products. The principles may also apply in other scenarios related to potency determination. This document should be read in conjunction with the referenced documents which provide further information.
Keywords: haemophilia A, haemophilia B, factor VIII and factor IX products