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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

September/October 2019; Volume 73,Issue 5

Guest Editorial

  • You have access
    PDA JPST Online Reboot
    Walter Morris
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 417; DOI: https://doi.org/10.5731/pdajpst.2019.001115

Research

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    Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
    Srivalli Telikepalli, Kristen Gonzalez, Sonia Dragulin-Otto, Dean Ripple, Michael Carrier and Mariam Khan
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 418-432; DOI: https://doi.org/10.5731/pdajpst.2018.008953
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    Sample Treatments That Solve Low Endotoxin Recovery Issues
    Masakazu Tsuchiya
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 433-442; DOI: https://doi.org/10.5731/pdajpst.2018.009464
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    Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process
    Devon Roshan Eisner, Aaron Hubbard, Kirk Eppler, Vassia Tegoulia and Yuh-Fun Maa
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 443-458; DOI: https://doi.org/10.5731/pdajpst.2019.009928
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    Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
    Saeedeh Aliaskarisohi, Marc Hogreve, Carole Langlois, Jonathan Cutting, Magali Barbaroux, Jean-Marc Cappia and Marie-Christine Menier
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 459-469; DOI: https://doi.org/10.5731/pdajpst.2018.009688
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    Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
    John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe and Louise Bennett
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 470-486; DOI: https://doi.org/10.5731/pdajpst.2018.009605
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    Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts
    Richard Denk, Andreas Flückiger, Hirokazu Kisaka, Stephan Krause, Reinhold Maeck, Lars Restetzki, Andreas Schreiner and Rico Schulze
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 487-495; DOI: https://doi.org/10.5731/pdajpst.2018.009530

Technology/Application

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    Charting and Evaluation of Real-Time Continuous Monitoring Water Bioburden
    Raphael Bar
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 496-509; DOI: https://doi.org/10.5731/pdajpst.2018.009837

Commentary

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    Fidelity to Science & Correct Scientific Vocabulary—Microbial Control Versus Contamination Control
    Edward C. Tidswell, Radha Tirumalai and David Hussong
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 510-516; DOI: https://doi.org/10.5731/pdajpst.2018.009795

PDA Paper

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    Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management
    Anders Vinther and Emma Ramnarine
    PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 517-521; DOI: https://doi.org/10.5731/pdajpst.2019.010827
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
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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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