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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

July/August 2019; Volume 73,Issue 4

Editorial

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    Editor's Note
    Richard Levy
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 292; DOI: https://doi.org/10.5731/pdajpst.2019.001114

Research

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    Measurement of Equilibration Time of Dry Goods Loads in Autoclaves
    Soham Shah, Sara Alayli and Yiming Peng
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 293-319; DOI: https://doi.org/10.5731/pdajpst.2018.009225
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    A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems—Part 2
    Laura M. Doyle (Drbohlav), Anant Navanithan Sharma, Ganapathy Gopalrathnam, Lihua Huang and Scott Bradley
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 320-330; DOI: https://doi.org/10.5731/pdajpst.2018.009639
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    Quality Risk Management Competency Model—Case for the Need for QRM Competencies
    Ghada Haddad and Anne Greene
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 331-344; DOI: https://doi.org/10.5731/pdajpst.2019.009944

Technology/Application

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    Comparative Leachable Study of Glass Vials to Demonstrate the Impact of Low Fill Volume
    Bernhard Hladik, Florence Buscke, Robert Frost and Uwe Rothhaar
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 345-355; DOI: https://doi.org/10.5731/pdajpst.2018.009472
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    Enabling Robust and Rapid Raw Material Identification and Release by Handheld Raman Spectroscopy
    Thomas E. Matthews, Christine Coffman, Dave Kolwyck, Dan Hill and Jason E. Dickens
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 356-372; DOI: https://doi.org/10.5731/pdajpst.2018.009563
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    Provable Data Integrity in the Pharmaceutical Industry Based on Version Control Systems and the Blockchain
    Valentin Steinwandter and Christoph Herwig
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 373-390; DOI: https://doi.org/10.5731/pdajpst.2018.009407

Commentary

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    What Does It Really Look Like to Properly Address a “Human Error Problem” in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance
    Clifford Berry, Brian Chviruk, Danny Hernandez, Matt Beaugard, Kelly B. Stevens, Joe Polizzotto, Lene Bjerregaard and Daan Purbrick
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 391-400; DOI: https://doi.org/10.5731/pdajpst.2018.009621

Conference Proceedings

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    PDA Biosimilars Workshop Report (September 27—28, 2018)—Getting It Right the First Time for Biosimilar Marketing Applications
    Stephan Krause, Emanuela Lacana, Joel Welch, Marjorie Shapiro, Christopher Downey, Jee Chung, Qing Zhou, Martijn Van Der Plas, Chantal Depatie, Bev Ingram, Catherine Srebalus-Barnes, Alla Polozova, Barbara Rellahan, Daeseok Choi, Richard Burdick, Thomas Stangler and Emily Shacter
    PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 401-416; DOI: https://doi.org/10.5731/pdajpst.2019.010215
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 4
July/August 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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