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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

September/October 2012; Volume 66,Issue 5

Editorial

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    Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India
    Anurag Rathore
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 393; DOI: https://doi.org/10.5731/pdajpst.2012.00886

Association Commentary

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    Pre-use/Post-sterilization Integrity Testing of Sterilizing Grade Filters
    PDA Pre Use/Post-Sterilization Integrity Test Task Force:, Karen Bartel, Hal Baseman, Gabriele Gori, Richard Levy, Hemisha Ly, Maik Jornitz, Russell Madsen, Michiel Rook and Sue Schniepp
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 394-395; DOI: https://doi.org/10.5731/pdajpst.2012.00885

Commentary

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    Considerations on Auditing and GxP Requirements along the Product Lifecycle
    Stephan Rönninger, Siegfried Schmitt, Vijaya Rangavajhula, Emily Hough and Jim Lyda
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 396-402; DOI: https://doi.org/10.5731/pdajpst.2012.00881

Research

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    Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
    Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer and Lei Li
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 403-419; DOI: https://doi.org/10.5731/pdajpst.2012.00878
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    A Survey of Quality Attributes of Virus Spike Preparations Used in Clearance Studies
    George Miesegaes, Scott Lute, Jessica Dement-Brown, Simran Kaushal, Daniel Strauss, Dayue Chen and Kurt Brorson
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 420-433; DOI: https://doi.org/10.5731/pdajpst.2012.00879
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    Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions
    Hirotaka Sudo, Michael O'driscoll, Kenji Nishiwaki, Yuji Kawamoto, Philip Gammell, Gerhard Schramm, Toni Wertli, Heino Prinz, Atsuhide Mori and Kazuhiro Sako
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 434-444; DOI: https://doi.org/10.5731/pdajpst.2012.00882

Technology/Application

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    Application of Flow Cytometry for Rapid Bioburden Screening in Vaccine Virus Production
    Praful K. Bhusari, David E. Tabor, Ryan Yamagata and Mark S. Galinski
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 445-452; DOI: https://doi.org/10.5731/pdajpst.2012.00883
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    Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
    Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes and Derek Duncan
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 453-465; DOI: https://doi.org/10.5731/pdajpst.2012.00884

Review

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    Drug Delivery from the Oral Cavity: A Focus on Mucoadhesive Buccal Drug Delivery Systems
    Dattatraya Manohar Shinkar, Avinash Sridhar Dhake and Chitral Mallikarjuna Setty
    PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 466-500; DOI: https://doi.org/10.5731/pdajpst.2012.00877
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
  • Low-Volume Aseptic Filling Using a Linear Peristaltic Pump
  • The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
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