Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators-Reference-Cited by-同舟云学术

Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators

Published:2015-01-27 Issue:4 Volume:21 Page:543-549
ISSN:1351-8216
Container-title:Haemophilia
language:en
Short-container-title:Haemophilia

Author:

Dodt J.¹,Hubbard A. R.²,Wicks S. J.³,Gray E.²,Neugebauer B.⁴,Charton E.³,Silvester G.⁴

Affiliation:

1. Paul-Ehrlich-Institut; Langen Germany

2. National Institute for Biological Standards and Control; Potters Bar UK

3. European Directorate for the Quality of Medicines and HealthCare; Strasbourg France

4. European Medicines Agency; London UK

Publisher

Wiley

Subject

Genetics (clinical),Hematology,General Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/hae.12634/fullpdf

Reference14 articles.

1. EMA 2009 Assessment report for Refacto AF http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000232/WC500049011.pdf

2. Collaborative field study on the utility of a BDD factor VIII concentrate standard in the estimation of BDDr Factor VIII: C activity in hemophilic plasma using one-stage clotting assays;Ingerslev;J Thromb Haemost,2004

3. Practical and cost-effective measurement of B-domain deleted and full-length recombinant FVIII in the routine haemostasis laboratory;Cauchie;Haemophilia,2013

4. Assaying FVIII activity: one method is not enough, and never was;Makris;Haemophilia,2014

5. EMA 2014 Joint EMA/EDQM workshop on characterisation of new clotting-factor concentrates (factor VIII and factor IX) with respect to potency assays used for labelling and testing of post-infusion samples http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2013/09/event_detail_000777.jsp&mid=WC0b01ac058004d5c3

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