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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

September/October 2013; Volume 67,Issue 5

Editorial

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    Waiter, There Is a Fly in My Soup!
    Govind Rao
    PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 412; DOI: https://doi.org/10.5731/pdajpst.2013.00949

PQRI Special Section

  • Commentary

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      Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products
      Daniel L. Norwood, Lee M. Nagao and Cheryl L. M. Stults
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 413-429; DOI: https://doi.org/10.5731/pdajpst.2013.00934
  • Review

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      The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP)
      Diane Paskiet, Dennis Jenke, Douglas Ball, Christopher Houston, Daniel L. Norwood and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 430-447; DOI: https://doi.org/10.5731/pdajpst.2013.00936
  • Research

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      Extractables Characterization for Five Materials of Construction Representative of Packaging Systems Used for Parenteral and Ophthalmic Drug Products
      Dennis Jenke, James Castner, Thomas Egert, Tom Feinberg, Alan Hendricker, Christopher Houston, Desmond G. Hunt, Michael Lynch, Arthur Shaw, Kumudini Nicholas, Daniel L. Norwood, Diane Paskiet, Michael Ruberto, Edward J. Smith and Frank Holcomb
      PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 448-511; DOI: https://doi.org/10.5731/pdajpst.2013.00933

Research

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    Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model
    Patrick J. McCormick, Michael J. Schoene, Matthew A. Dehmler, James J. Kaiser, Susan E. Norton, Alexandre Pizon and Mark A. Fornalik
    PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 512-532; DOI: https://doi.org/10.5731/pdajpst.2013.00932

Research

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    Setting Specifications of Correlated Quality Attributes through Multivariate Statistical Modelling
    Harry Yang
    PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 533-543; DOI: https://doi.org/10.5731/pdajpst.2013.00935

Research

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    Application of the Finite Elemental Analysis to Modeling Temperature Change of the Vaccine in an Insulated Packaging Container during Transport
    Changfeng Ge, Yujie Cheng and Yan Shen
    PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 544-552; DOI: https://doi.org/10.5731/pdajpst.2013.00937

Commentary

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    The Application of Quality Risk Management to the Bacterial Endotoxins Test: Use of Hazard Analysis and Critical Control Points
    Carducci Annalaura, Davini Giulia and Ceccanti Stefano
    PDA Journal of Pharmaceutical Science and Technology September 2013, 67 (5) 553-567; DOI: https://doi.org/10.5731/pdajpst.2013.00938
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 5
September/October 2013
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  • Delamination Propensity of Pharmaceutical Glass Containers by Accelerated Testing with Different Extraction Media
  • Microbial Diversity in Pharmaceutical Product Recalls and Environments
  • Pharmaceutical Container/Closure Integrity II: The Relationship Between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials
  • Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials
  • Leak Testing in Parenteral Packaging: Establishment of Direct Correlation between Helium Leak Rate Measurements and Microbial Ingress for Two Different Leak Types
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