000			02408cam a2200289 4500
001			9241208481
020			_a9241208481
035			_a(Sirsi) 9241208481
060			_aQW 800
111	2		_aWHO Expert Committee on Biological Standardization.
245	0	0	_aWHO Expert Committee on Biological Standardization [meeting held in Geneva from 12 to 19 October 1993] : _bforty-fourth report.
260			_aGeneva : _bWorld Health Organization, _c1994.
300			_a88 p.
440		0	_aWHO technical report series ; _v848
520	3		_aReports the work of an expert committee commissioned to identify and establish international standards and reference reagents for biological substances. Held and distributed by WHO International Laboratories for Biological Standards, these reference materials are widely used by national control authorities and manufacturers to ensure worldwide uniformity when designating the potency, activity, or specificity of biologicals used in prophylaxis, therapy or diagnosis of disease. The committee also issues guidelines and detailed requirements for the manufacturing and quality control of selected biologicals. The report has two parts. The first part briefly considers general issues affecting the committee s work, explains the decision to issue new or revised requirements for two vaccines, and reviews the need to establish, replace, or discontinue some 55 international reference materials. Ten new or replacement reference materials were established. The second and most extensive part issues detailed requirements for the manufacturing and quality control of two vaccines. Revised requirements were issued for live varicella vaccine. Revisions reflect the extensive experience gained by manufacturers since the initial requirements were established in 1984. The committee also issued new requirements for inactivated vaccine against haemorrhagic feverwith renal syndrome, an acute interstitial nephropathy caused by viruses belonging to the Hantavirus genus of the family Bunyaviridae.
535			_aDC.HQ
546			_aeng fre rus spa.
550			_aWHODOC
561			_aWHO monograph
596			_a4
650	0	2	_aBiological products _xstandards.
690			_aPharmaceuticals and Biologicals.
710	2		_aWorld Health Organization.
856			_uhttps://apps.who.int/iris/
008			941117s1994 0 eng
942			_2NLM _cMONOGRAPH
999			_c13953 _d13953