A multi-centre collaborative study on the potency estimation of ReFacto

Thrombosis and Haemostasis

Volumn 90, Issue 6, 2003, Pages 1088-1093

  Hubbard, Anthony R ^a   Sands, Dawn ^a   Sandberg, Eva ^b   Seitz, Rainer ^c   Barrowcliffe, Trevor W ^a  

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

^b DANISH MEDICINES AGENCY   (Denmark)

^c PAUL EHRLICH INSTITUT   (Germany)

Author keywords

Chromogenic assays; Factor VIII; Haemophilia A

Indexed keywords

BLOOD CLOTTING FACTOR 8 CONCENTRATE; RECOMBINANT BLOOD CLOTTING FACTOR 8;

ARTICLE; BIOASSAY; CALCULATION; CHROMOGENIC ASSAY; COMPARATIVE STUDY; CONTROLLED STUDY; DEVICE; DRUG ACTIVITY; DRUG DETERMINATION; DRUG MANUFACTURE; DRUG POTENCY; DRUG QUALITY; LABORATORY; MEDICAL LITERATURE; METHODOLOGY; MICROTITER PLATE ASSAY; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; STANDARD; WORLD HEALTH ORGANIZATION;

EID: 0347043611     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/th03-02-0082     Document Type: Article

References (14)

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14. EMEA Public Statement on ReFacto (Moroctocog Alfa) Prepared by the Committee for Proprietary Medicinal Products (CPMP) (May 2003). Introduction of a change to ReFacto drug product specific activity specification increase of 20% in the amount of ReFacto protein in each vial. CPMP/2337/03.