The control and standardisation of biological medicines
| Autor: | Philip D. Minor, Geoffrey C. Schild, Michael J. Corbel, R. Gaines-Das, S. L. Jeffcoate |
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| Rok vydání: | 1993 |
| Předmět: | |
| Zdroj: | Proceedings of the Royal Society of Edinburgh. Section B. Biological Sciences. 101:207-226 |
| ISSN: | 2053-5910 0269-7270 |
| DOI: | 10.1017/s0269727000005753 |
| Popis: | SynopsisAssuring 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. |
| Databáze: | OpenAIRE |
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