International collaborative study to establish reference preparations to standardise haemagglutination testing for Anti-A and Anti-B in normal intravenous Immunoglobulins by the direct method

Last updated on 23-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph



A joint project (coded BSP089) was run by the European Directorate for the Quality of Medicines & HealthCare (EDQM)of the Council of Europe, the National Institute for Biological Standards and Control (NIBSC) on behalf of the WorldHealth Organization (WHO) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and DrugAdministration (FDA) to evaluate, in an international collaborative study, 3 lyophilised intravenous immunoglobulin(IVIG) preparations for their suitability to serve as Reference Preparations to standardise and control the highly variablehaemagglutination…

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