The outcome of the successful study for the establishment of the European Pharmacopoeia (Ph. Eur.) Prekallikrein Activator (PKA) in Albumin Biological Reference Preparation (BRP) batches 8, 9 and 10 has been published in Pharmeuropa Bio & Scientific Notes, the online scientific journal of the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Twenty-four laboratories – including Official Medicines Control Laboratories and manufacturers from Europe and beyond – took part in the study (BSP167) using their routine assay method. The three BRP candidate batches were evaluated and found to be suitable for their intended purpose. Details of the materials and methods used, in addition to the results, statistical analysis and conclusion, are given in the online article.
The organisers warmly thank all the participants for their valuable contribution and for their support of the Biological Standardisation Programme (BSP), a joint programme of the Council of Europe and the European Commission.
Pharmeuropa Bio & Scientific Notes is published by the EDQM and referenced on MedLine.
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