Virological safety aspects of plasma derivatives : cannes(France) November 3-6, 1992
著者
書誌事項
Virological safety aspects of plasma derivatives : cannes(France) November 3-6, 1992
（Developments in biological standardization, v. 81）
Karger, c1993
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注記
Proceedings of a Symposium organized by the International Association of Biological Standardization and co-sponsored by the World Health Organization, the Council of Europe, European Pharmacopoeia, the International Society of Blood Transfusion and the Department of Health & Human Services F.D.A.(USA)
内容説明・目次
内容説明
Human plasma pools used for the preparation of therapeutic products are known to carry a certain risk of transmitting viruses which cause diseases such as AIDS and hepatitis B and C. This volume brings the reader up to date with the efforts being made at all levels to ensure the safety of plasma-derived products. Emphasis is placed on the factors most important for product safety, such as donor selection, testing of individual units, control of the manufacturing process, the use of inactivation and/or elimination procedures, and end-product testing for infectious agents. Regulatory activities and the role of the WHO are also discussed. With contributions from leading experts, this volume is a valuable resource for all those concerned with the virological safety of plasma derivatives.
目次
- Opening conference - hepatitis overview - viral hepatitis - one disease but multiple viruses, J.L. Melnick
- session I - virology and epidemiology, chairman - F. Horaud
- session II - selection of source material, chairman - J.W. Mosley
- session III - testing for viral markers, chairman - J. Finlayson
- session IV - general considerations on viral inactivation and/or elimination, chairman - I. Gust
- session V - critical views on methods used for viral inactivation and/or elimination, chairman - W.G. van Aken
- session VI - validation of viral inactivation and/or elimination, chairman - G. Schild
- session VII - regulatory aspects of safety, chairman - I. Sjoholm
- session VIII - summary and conclusion, chairman - G. Vicari.
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