Chromogenic assay of human coagulation factor VIII: statistical comparison of 2 working dilution procedures.
The effect of 2 different practices for preparation of working dilutions in the chromogenic substrate method for potency assay of factor VIII was evaluated. In this study the potency of several concentrate materials was shown to be statistically equivalent, whether performing the assay with independent or serial working dilutions.
Agencia Española de Medicamentos y Productos Sanitarios, 28220 Majadahonda, Madrid, Spain. calonso@agemed.es
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Alonso
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Gonzalez
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Frutos
D000465:Algorithms; D002863:Chromogenic Compounds / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D005169:Factor VIII / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D006801:Humans; D007201:Indicator Dilution Techniques / Q000592:standards / Q000706:statistics & numerical data; D015233:Models, Statistical; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods
D002863:Chromogenic Compounds; D005169:Factor VIII