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001			ebr10075419
003			CaPaEBR
006			m u
007			cr cn|||||||||
008			050120s2004 sz a sb i100 0 eng d
020			_z9241209240
040			_aCaPaEBR _cCaPaEBR
035			_a(OCoLC)559332398
050	1	4	_aRA8 _b.A25 no. 924 2004eb
110	2		_aWHO Expert Committee on Biological Standardization. _bMeeting _n(52nd : _d2001 : _cGeneva, Switzerland)
245	1	0	_aWHO Expert Committee on Biological Standardization _h[electronic resource] : _bfifty-second report.
260			_aGeneva : _bWorld Health Organization, _c2004.
300			_avii, 232 p. : _bill.
490	1		_aWHO technical report series, _x0512-3054 ; _v924
500			_a"The WHO Expert Committee on Biological Standardization met in Geneva from 26 to 30 November 2001"--Introd.
504			_aIncludes bibliographical references.
505	0		_a505 0 Introduction -- General. Developments in biological standardization. Bioterrorism. International nonproprietary names for biotechnology-derived medicinal products -- International guidelines, recommendations, and other matters related to the manufacture and quality control of biologicals. Guidelines on clinical evaluation of vaccines: regulatory expectations. Group C meningococcal conjugate vaccines. Inactivated oral cholera vaccines. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. Pneumococcal conjugate vaccines. Potency assays for diphtheria and tetanus vaccines. Pertussis vaccines. Preventive human immunodeficiency virus vaccines. Cell substrate safety. Cell banks. Yellow fever. Poliomyelitis vaccine, oral. Transmissible spongiform encephalitis and the safety of biologicals. Antivenoms. Gene therapy. Discontinuation requirements -- International reference materials. Biological substances: international standards and reference reagents. International biological standards for in vitro diagnostic procedures. International reference materials for the diagnosis and study of transmissible spongiform encephalitis -- Antibodies. Human antibody against human platelet antigen 5b -- Blood products and related substances. International reference panels for the validation of serological and nucleic acid based test for the detection of hepatitis B, hepatitis C and human immunodeficiency virus in blood screening. Factors II, VII, X, plasma. Von Willebrand factor. Streptokinase. Unfractioned heparin and low-molecular-weight heparin -- Cytokines, growth factors and endocrinological substances. Human chorionic gonadotrophin. Ciliary neurotrophic factor. Prolactin and its glycosylated and non-glycosylated components -- Miscellaneous. Pertussis toxin standard -- Annex 1. Guidelines on clinical evaluation of vaccines: regulatory expectations -- Annex 2. Recommendations for the production and control of meningococcal group C conjugate vaccines -- Annex 3. Guidelines for the production and control of inactivated oral cholera vaccines -- Annex 4. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood products -- Annex 5. Biological substances: international standards and reference reagents -- Annex 6. Recommendations and guidelines for biological substances used in medicine and other documents.
533			_aElectronic reproduction. _bPalo Alto, Calif. : _cebrary, _d2009. _nAvailable via World Wide Web. _nAccess may be limited to ebrary affiliated libraries.
650		0	_aBiological products _xStandards _vCongresses.
650		0	_aDrugs _xStandards _vCongresses.
655		7	_aElectronic books. _2local
710	2		_aebrary, Inc.
830		0	_aTechnical report series (World Health Organization) ; _v924.
856	4	0	_uhttp://site.ebrary.com/lib/rucke/Doc?id=10075419 _zAn electronic book accessible through the World Wide Web; click to view
999			_c45628 _d45628