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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

November/December 2015; Volume 69,Issue 6

Editor's Note

  • You have access
    Preventing a Pharma Crash: A 30,000 Foot View
    Govind Rao
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 666; DOI: https://doi.org/10.5731/pdajpst.2015.01091

Editorial

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    Taking Flight
    Norman R. Augustine
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 667-668; DOI: https://doi.org/10.5731/pdajpst.2015.01092

Research

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    Filtration of Glass Delamination Particles with West Pharmaceutical Vial Adapters
    Elinor H. Zarour-Shalev, Yaron Ovadia, Oren Tuchmay, Graham Reynolds and Nimrod Lev
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 669-676; DOI: https://doi.org/10.5731/pdajpst.2015.01076
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    Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 677-712; DOI: https://doi.org/10.5731/pdajpst.2015.01077
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    Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper
    Hideaki Kiminami, Katsuyuki Takeuchi, Koji Nakamura, Yoshihiko Abe, Philippe Lauwers, William Dierick, Keisuke Yoshino and Shigeru Suzuki
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 713-724; DOI: https://doi.org/10.5731/pdajpst.2015.01080
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    A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error
    Harry Yang and Jianchun Zhang
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 725-735; DOI: https://doi.org/10.5731/pdajpst.2015.01081

Technology/Application

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    Increasing Product Confidence—Shifting Paradigms
    Marla Phillips, Vishal Kashyap and Mee-Shew Cheung
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 736-742; DOI: https://doi.org/10.5731/pdajpst.2015.01075
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    Charting and Evaluation of Environmental Microbial Monitoring Data
    Raphael Bar
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 743-761; DOI: https://doi.org/10.5731/pdajpst.2015.01079

Case Study

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    Data Integrity—A Study of Current Regulatory Thinking and Action
    Nader Shafiei, Regis De Montardy and Edwin Rivera-Martinez
    PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 762-770; DOI: https://doi.org/10.5731/pdajpst.2015.01082
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 6
November/December 2015
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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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