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Book Cover
E-book
Author WHO Expert Committee on Biological Standardization. Meeting (52nd : 2001 : Geneva, Switzerland)

Title WHO Expert Committee on Biological Standardization : fifty-second report
Published Geneva : World Health Organization, 2004

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Description 1 online resource (vii, 232 pages) : illustrations
Series WHO technical report series ; 924
Technical report series (World Health Organization) ; 924.
Contents 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
Summary Annotation This publication contains the recommendations of a WHO Expert Committee, which met in Geneva in November 2001, relating to quality and standardisation of biological products. Aspects discussed include: the production and quality control of meningococcal group C conjugate vaccines; guidelines for regulatory expectations for clinical evaluation of vaccines; guidelines for the production and quality control of inactivated oral cholera vaccines; guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products; information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances
Bibliography Includes bibliographical references
Notes English
In Academic Search Complete. EBSCO
Subject Biological products -- Standards -- Congresses
Drugs -- Standards -- Congresses
Biological products -- Standards
Drugs -- Standards
Genre/Form Conference papers and proceedings
Form Electronic book
Author World Health Organization
ISBN 9240681523
9789240681521
9786610097432
6610097437
9789241209243
9241209240
9781280097430
1280097434