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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.
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.