title: International reference preparations for standardization of biological medicinal products.
abstract: 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 proved valuable in assaying the activity of therapeutic biological medicines and in standardizing certain types of diagnostics. Issues arise with maintaining the unit when the primary reference must be replaced and to some extent in assessing the commutability of the reference with real life analytes.
authors.affiliation: Division of Virology, National Institute of Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, EN6 3QG, Hertfordshire, United Kingdom, Philip.Minor@nibsc.org.
authors.forename: P
authors.initials: P
authors.lastname: Minor
mesh_terms: D001681:Biological Assay / Q000592:standards*; D001688:Biological Products / Q000592:standards*; D004341:Drug Evaluation / Q000592:standards*; D007394:International System of Units / Q000592:standards*; D038622:Internationality; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012016:Reference Values; D014944:World Health Organization / Q000458:organization & administration
chemical_list: D001688:Biological Products; D004364:Pharmaceutical Preparations