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

Haemophilia

Volumn 21, Issue 4, 2015, Pages 543-549

  Dodt, J ^a   Hubbard, A R ^b   Wicks, S J ^c   Gray, E ^b   Neugebauer, B ^d   Charton, E ^c   Silvester, G ^d  

^a PAUL EHRLICH INSTITUT   (Germany)

^b NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^c European Directorate for the Quality of Medicines and Health Care   (France)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

New factor VIII and factor IX; Postinfusion testing; Potency assays

Indexed keywords

BLOOD CLOTTING FACTOR 8 CONCENTRATE; BLOOD CLOTTING FACTOR 9 CONCENTRATE; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT BLOOD CLOTTING FACTOR 9; THROMBOPLASTIN; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; CHROMOGENIC SUBSTRATE; RECOMBINANT PROTEIN;

ARTICLE; BLOOD CLOTTING TEST; CHROMOGENIC FACTOR XIII ASSAY; CORRELATION ANALYSIS; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG INFORMATION; DRUG LABELING; DRUG MANUFACTURE; DRUG POTENCY; DRUG QUALITY; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HEMOPHILIA A; HEMOPHILIA B; HUMAN; IN VIVO STUDY; LABORATORY TEST; MEDICAL LITERATURE; PARTIAL THROMBOPLASTIN TIME; PATIENT MONITORING; PRIORITY JOURNAL; UNITED KINGDOM; WORKSHOP; CALIBRATION; CAREGIVER; CHEMISTRY; INTERNATIONAL COOPERATION; LABORATORY; METABOLISM; PACKAGING; PSYCHOLOGY; STANDARDS;

BLOOD COAGULATION TESTS; CALIBRATION; CAREGIVERS; CHROMOGENIC COMPOUNDS; FACTOR IX; FACTOR VIII; HUMANS; INTERNATIONAL COOPERATION; LABORATORIES; PARTIAL THROMBOPLASTIN TIME; PRODUCT LABELING; RECOMBINANT PROTEINS;

EID: 84931956043     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12634     Document Type: Article

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