| Current challenges in viral safety and extraneous agent testing. | |
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MedLine Citation:
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PMID: 20338787 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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There are three principal elements related to viral safety in the context of immunological veterinary medicinal products: the presence of extraneous agents in either raw material used for production or in the finished product, residual pathogenicity of live viruses used as active ingredients, and incomplete inactivation of inactivated viruses used as active ingredients. Although the approach to controlling these areas of risk has not substantially changed in the recent past, a number of events, combined with advances in science and changes in the regulatory approach, make it timely to review the requirements in this area. This article reviews the major areas of change and progress with respect to the viral safety of immunological veterinary medicinal products and identifies current challenges from the perspectives of both industry and regulators. |
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Authors:
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David Mackay; Nikolaus Kriz |
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Publication Detail:
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Type: Journal Article; Review Date: 2010-03-24 |
Journal Detail:
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Title: Biologicals : journal of the International Association of Biological Standardization Volume: 38 ISSN: 1095-8320 ISO Abbreviation: Biologicals Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-05-21 Completed Date: 2010-08-31 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9004494 Medline TA: Biologicals Country: England |
Other Details:
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Languages: eng Pagination: 335-7 Citation Subset: IM |
Copyright Information:
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2010. Published by Elsevier Ltd. |
Affiliation:
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EMEA, 7 Westferry Circus, Canary Wharf, London E144HB, United Kingdom. david.mackay@emea.europa.eu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Drug Contamination / prevention & control* Humans Risk Assessment / methods Risk Factors Vaccination / veterinary Veterinary Medicine / methods, standards Viral Vaccines / analysis*, immunology, standards* Viruses / immunology |
| Chemical | |
Reg. No./Substance:
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0/Viral Vaccines |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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