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WHO Expert Committee on Biological Standardization : sixtieth report /
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. Th...
| Clasificación: | Libro Electrónico |
|---|---|
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Geneva, Switzerland :
World Health Organization,
[2013]
|
| Colección: | Technical report series (World Health Organization) ;
977. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Contents; Introduction; General; Strategic directions in biological standardization; Vaccines and biological therapeutics: recent and planned activities in biological standardization; Blood products and related in vitro diagnostics: recent and planned activities in biological standardization; Blood Regulators Network; Reports from the WHO international laboratories and collaborating centres for biological standards; National Institute for Biological Standards and Control, Potters Bar, England.
- WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices, Paul-Ehrlich-Institute, Langen, GermanyCenter for Biologics Evaluation and Research (CBER), Food and Drug Administration, Bethesda, USA; Reports from international groups establishing secondary standards; Issues shared with the WHO Expert Committee on Specifications for Pharmaceutical Preparations; Pharmaceutical cold-chain management; Nomenclature of stem cells; International Recommendations, Guidelines, and other matters related to the manufacture and quality control of biologicals.
- Guidelines for independent lot release of vaccines by regulatory authoritiesGuidelines on evaluation of similar biotherapeutic products (SBPs); Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines; Recommendations to assure the quality, safety and efficacy of live attenuated influenza vaccines; Good manufacturing practices for manufacturing blood products for transfusion; Convalescent plasma; Snake bite envenomings and antivenoms; International reference materials
- antigens and related substances; Inactivated poliovirus vaccines (trivalent).
- Poliovirus type 1 (Sabin)Human papillomavirus type 16 antibodies; Bordetella pertussis serotype 2 and serotype 3; BCG vaccine; Diphtheria vaccine (adsorbed); International reference materials
- blood products and related substances; International Society on Thrombosis and Haemostasis report; Blood coagulation factor VIII, concentrate; Blood coagulation factor VIII and von Willebrand factor (VWF), plasma; Streptodornase; Unfractionated heparin; International reference materials
- cytokines, growth factors and endocrinological substances; Chorionic gonadotrophin, human.
- Parathyroid hormone, 1-84, human recombinantInternational reference materials
- diagnostic reagents; HIV-2 RNA; Hepatitis B virus DNA; Parvovirus B19 DNA; Thromboplastin, human, recombinant plain; Soluble transferrin receptor; Prader-Willi and Angelman syndromes; Fusion gene BCR-ABL; Proposed new reference preparation projects; Antigens and related substances; Human papillomavirus (HPV) type 6 DNA and type 11 DNA
- proposed International Standards; Purified human genomic DNA; Typhoid antibodies
- proposed International Standards.
- Antibodies (human) to influenza A virus
- proposed International Standards.