Index by Author

November/December 2011; Volume 65,Issue 6

Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010

  1. Duncan, P.

    1. Adventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine Circovirus
      C. S. Ranucci, T. Tagmyer and P. Duncan
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 589-598; DOI: https://doi.org/10.5731/pdajpst.2011.00827

  2. Eltermann, John

    1. Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
      John Eltermann
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 694-697; DOI: https://doi.org/10.5731/pdajpst.2011.00845

  3. Farshid, Mahmood

    1. Viral Safety of Plasma-derived Products
      Mahmood Farshid
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 737-753; DOI: https://doi.org/10.5731/pdajpst.2011.00848

  4. Friedman, Richard L.

    1. FDA Post-Approval Expectations for Adventitious Virus Contamination Prevention
      Richard L. Friedman
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 698-712; DOI: https://doi.org/10.5731/pdajpst.2011.00846

  5. Friedman, Rick

    1. Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices
      Amy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick Friedman
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820

  6. Gardner, Shea

    1. Detection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection Array
      Crystal Jaing, Shea Gardner, Kevin McLoughlin, James B. Thissen and Tom Slezak
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 668-674; DOI: https://doi.org/10.5731/pdajpst.2011.00838

  7. Gregersen, Jens-Peter

    1. Theory and Practice of Conventional Adventitious Virus Testing
      Jens-Peter Gregersen
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 634-644; DOI: https://doi.org/10.5731/pdajpst.2011.00832

  8. Hendricks, Linda C.

    1. Case Study of Apparent Virus Contamination in Biopharmaceutical Product at Centocor
      Linda C. Hendricks and Dominick A. Vacante
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 612-613; DOI: https://doi.org/10.5731/pdajpst.2011.00825

  9. Hughes, Patricia

    1. Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices
      Amy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick Friedman
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
    2. Introduction to Workshop: Adventitious Viruses in Biologics—Detection and Mitigation Strategies
      Arifa S. Khan, Patricia Hughes and Michael Wiebe
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 544-546; DOI: https://doi.org/10.5731/pdajpst.2011.00817

  10. Ill, Richard C.

    1. Evaluation of a Single-Platform, Rapid, Nucleic Acid–Based Technology for Detection of Adventitious Contaminants of Cell Culture
      Houman Dehghani, Bill Lawrence and Richard C. Ill
      PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 675-680; DOI: https://doi.org/10.5731/pdajpst.2011.00840
« Previous (Pages : 1 2 3 4 5 6 ... 6) Next »
Back to top

In This Issue