03929nam a2200325Ia 4500 ebr10075419 CaPaEBR m u cr cn||||||||| 050120s2004 sz a sb i100 0 eng d 9241209240 CaPaEBR CaPaEBR (OCoLC)559332398 RA8 .A25 no. 924 2004eb WHO Expert Committee on Biological Standardization. Meeting (52nd : 2001 : Geneva, Switzerland) WHO Expert Committee on Biological Standardization [electronic resource] : fifty-second report. Geneva : World Health Organization, 2004. vii, 232 p. : ill. WHO technical report series, 0512-3054 ; 924 "The WHO Expert Committee on Biological Standardization met in Geneva from 26 to 30 November 2001"--Introd. Includes bibliographical references. 505 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. Electronic reproduction. Palo Alto, Calif. : ebrary, 2009. Available via World Wide Web. Access may be limited to ebrary affiliated libraries. Biological products Standards Congresses. Drugs Standards Congresses. Electronic books. local ebrary, Inc. Technical report series (World Health Organization) ; 924. http://site.ebrary.com/lib/rucke/Doc?id=10075419 An electronic book accessible through the World Wide Web; click to view 45628 45628