The outcome of a successful study on the determination of procoagulant activity in human normal immunoglobulin preparations for therapeutic use by FXIa chromogenic assay has recently been published in the EDQM online journal Pharmeuropa Bio & Scientific Notes. The article details the methods used, statistical analysis of the results as well as conclusions of the study which was run under the aegis of the Biological Standardisation Programme (BSP) as project BSP143. The BSP is a joint programme funded by the European Union and the Council of Europe and coordinated by the EDQM in which laboratories from around the world collaborate.
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