WHO Expert Committee on Biological Standardization.

B. Horowitz, P. Minor, J. J. Morgenthaler, T. Burnouf, R. McIntosh, A. Padilla, R. Thorpe, W. G. van Aken

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6 引文 斯高帕斯(Scopus)


This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains recommendations for 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 and guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products.
期刊World Health Organization technical report series
出版狀態已發佈 - 2004

ASJC Scopus subject areas

  • 公共衛生、環境和職業健康


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