عنوان

WHO Expert Committee on Biological Standardization :

1280097434

6610097437

9240681523

9241209240

9781280097430

9786610097432

9789240681521

9789241209243

9241209240

b755863

WHO Expert Committee on Biological Standardization :

[Book]

fifty-second report.

Geneva :

World Health Organization,

2004.

1 online resource (vii, 232 pages) :

illustrations

WHO technical report series ;

924

Includes bibliographical references.

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.

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Annotation

MIL

009743

WHO Expert Committee on Biological Standardization.

Academic Search Complete.

Biological products-- Standards, Congresses.

Drugs-- Standards, Congresses.

Biological products-- Standards.

Drugs-- Standards.

WHO Expert Committee on Biological Standardization., Meeting(52nd :2001 :, Geneva, Switzerland)

World Health Organization.

20201204160751.0

pn

[Book]

Y