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Research ArticleConference Proceeding

Testing Considerations for Novel Cell Substrates: A Regulatory Perspective

A. S. Khan
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 426-431;
A. S. Khan
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  • For correspondence: Arifa.Khan@fda.hhs.gov
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Article Information

vol. 64 no. 5 426-431
PubMed 
21502046

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. A. S. Khan*
  1. Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, MD, USA
  1. * Address for correspondence: Dr. A. S. Khan, Laboratory of Retroviruses, Division of Viral Products, Office of Vaccines Research and Review, CBER/FDA, Bldg. 29B, Room 4NN10, HFM-454, 8800 Rockville Pike, Bethesda, MD 20892 USA. Arifa.Khan{at}fda.hhs.gov
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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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Testing Considerations for Novel Cell Substrates: A Regulatory Perspective
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 426-431;

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Testing Considerations for Novel Cell Substrates: A Regulatory Perspective
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 426-431;
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  • Article
    • Abstract
    • Introduction
    • Transition in Cell Substrates
    • Safety Issues Related to Novel Cell Substrates
    • Comprehensive Safety Scheme for Cell Substrate Testing
    • General Considerations for Product Safety
    • Acknowledgments
    • References
  • Figures & Data
  • Info & Metrics
  • References
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  • Current Testing Methods and Challenges for Detection of Adventitious Viruses
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