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The control and standardisation of biological medicines

Published online by Cambridge University Press:  05 December 2011

S. L. Jeffcoate ,
M. J. Corbel ,
P. D. Minor ,
R. Gaines-Das  and
G. C. Schild
S. L. Jeffcoate
Affiliation:
National Institute for Biological Standards and Control, Potters Bar, Herts
M. J. Corbel
Affiliation:
National Institute for Biological Standards and Control, Potters Bar, Herts
P. D. Minor
Affiliation:
National Institute for Biological Standards and Control, Potters Bar, Herts
R. Gaines-Das
Affiliation:
National Institute for Biological Standards and Control, Potters Bar, Herts
G. C. Schild
Affiliation:
National Institute for Biological Standards and Control, Potters Bar, Herts
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Synopsis

Assuring the quality, safety and efficacy of the complex medicinal drugs known as ‘biologicals’ has many facets of importance to public health. This survey covers the historical basis of this area of medical science through current issues and practices to the anticipation of future challenges. The key role of the World Health Organization in promoting international biological standardisation and of biostatistics in the design and analysis of biological assays is emphasised. Examples of the importance of quality control and standardisation are drawn especially from the fields of bacterial and viral vaccines. Assurance of the quality of these is essential for the successful implementation of childhood vaccination programmes aimed at the reduction and eradication of communicable diseases worldwide.

Type
Research Article
Information
Proceedings of the Royal Society of Edinburgh, Section B: Biological Sciences , Volume 101: Quality Assurance in Medical Care , 1993 , pp. 207 - 226
Copyright
Copyright © Royal Society of Edinburgh 1993

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References

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