Establishment of Replacement Batches for Prekallikrein Activator in Albumin Biological Reference Preparation

Last updated on 22-8-2019 by Anonymous (non vérifié)

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



A collaborative study was run by the European Directorate for the Quality of Medicines and HealthCare (EDQM) under the aegis of the Biological Standardisation Programme (BSP) to establish replacement batches of the current Prekallikrein activator in albumin Biological Reference Preparation (BRP) batch 1, the stocks of which were dwindling. Candidate BRP replacement batch 2 and batch 3 were assayed against the 2nd World Health Organization International Standard for Prekallikrein activator, human (2nd IS) and the Prekallikrein activator in albumin BRP batch 1.The candidate batches were manuf…

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