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Research ArticleConference Proceeding

Regulatory Expectations of Validation/Qualification of Adventitious Virus Assays

S. A. Baylis and J. BlÜmel
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 486-491;
S. A. Baylis
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J. BlÜmel
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Article Information

vol. 64 no. 5 486-491
PubMed 
21502057

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 12, 2010.

Copyright & Usage 
© PDA, Inc. 2010

Author Information

  1. S. A. Baylis and
  2. J. BlÜmel
  1. Division of Virology, Paul-Ehrlich-Institut, Langen, Germany
  1. Corresponding Author: Dr. S. A. Baylis, Division of Virology, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany. Telephone: +49(0) 6103 77 3803. Fax: +49 (0) 6103 77 1285. E-mail: baysa{at}pei.de
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PDA Journal of Pharmaceutical Science and Technology: 64 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
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Regulatory Expectations of Validation/Qualification of Adventitious Virus Assays
S. A. Baylis, J. BlÜmel
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 486-491;

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Regulatory Expectations of Validation/Qualification of Adventitious Virus Assays
S. A. Baylis, J. BlÜmel
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 486-491;
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  • Article
    • Abstract
    • Introduction
    • Quality Considerations
    • Assay Parameters
    • Nucleic Acid Amplification Technique (NAT) Testing of Plasma for HCV and B19V
    • Requirements for Assay Validation
    • Conclusions and Future Perspectives
    • Acknowledgements
    • References
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