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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

September/October 2017; Volume 71,Issue 5

Editorial

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    You “Like” Us!
    Govind Rao
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 328-329; DOI: https://doi.org/10.5731/pdajpst.2017.001103

Review

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    2015/2016 Quality Risk Management Benchmarking Survey
    Kelly Waldron, Emma Ramnarine and Jeffrey Hartman
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 330-345; DOI: https://doi.org/10.5731/pdajpst.2017.007526

Research

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    Extractables Screening of Polypropylene Resins Used in Pharmaceutical Packaging for Safety Hazards
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 346-367; DOI: https://doi.org/10.5731/pdajpst.2016.007401
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    A Novel Lack-of-Fit Assessment as a System Suitability Test for Potency Assays
    Ruojia Li, Weiguo Cai and Marcel Zocher
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 368-378; DOI: https://doi.org/10.5731/pdajpst.2016.007369

Technology/Application

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    Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
    Christopher L. Timmons, Chi Yuen Liu and Stefan Merkle
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 379-392; DOI: https://doi.org/10.5731/pdajpst.2017.007724
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    Evaluation of Novel Process Indicators for Rapid Monitoring of Hydrogen Peroxide Decontamination Processes
    N. P. McLeod, M. Clifford and J. M. Sutton
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 393-404; DOI: https://doi.org/10.5731/pdajpst.2016.007435
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    Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products
    Jay Bolden and Kelly Smith
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 405-412; DOI: https://doi.org/10.5731/pdajpst.2017.007849

Commentary

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    Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective
    Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis and David Bain
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 413-420; DOI: https://doi.org/10.5731/pdajpst.2016.007351

PDA Papers

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    PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?
    Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kara Follman, Karolyn Gale, Kassidy Good, Suzanne Kiani, Maik Jornitz, Morten Munk, Kevin O'Donnel, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther, Denyse Baker and Rich Levy
    PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 421-427; DOI: https://doi.org/10.5731/pdajpst.2017.008219
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 5
September/October 2017
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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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