International reference preparations for standardization of biological medicinal products
Minor, P. · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · 2014 · Heft 9 · S. 1145 bis 1151
Bibliografische Angaben
Zusammenfassung
International standards are prepared as materials assigned an arbitrary unitage for a biological activity by the Expert Committee on Biological Standardization of the World Health Organization. Working reference materials are calibrated against international standards giving a common unit of measurement between laboratories. The references are assessed by a collaborative study including all relevant assays rather than by a single reference method as in the SI (Le Système international d’unités) system and the unitage assigned is an arbitrary value derived from a consensus of all valid methods. The process has pr…