Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6

Last updated on 22-8-2019 by Anonymous (not verified)

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

SCIENSANO

Abstract:

An international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to calibrate replacement batches for thecurrent European Pharmacopoeia (Ph. Eur.) prekallikrein activator (PKA) in albumin biological reference preparation (BRP), whose stocks were dwindling. The study was run in the frameworkof the Biological Standardisation Programme (BSP) of the Council of Europe and the European Union (EU) Commission. Twenty three laboratories from official medicines control authoritiesand manufacturers in Europe and outside …

Associated health topics:

QR code

QR code for this page URL