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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

November/December 2021; Volume 75,Issue 6

Research

  • You have access
    Validating Container Closure Integrity with Statistically Based Tests
    Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas and Maury Mossman
    PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 465-473; DOI: https://doi.org/10.5731/pdajpst.2020.012622
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    Method Comparison Study—One Step Forward toward Robust Silicone Layer Thickness Measurements
    Safia Lotfi, Fabio Montagner, Christian Proff, Sascha Dreher, Ulla Grauschopf, Chiara De Zorzi, Odra Pinato, Serena Panighello and Stefanie Funke
    PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 474-489; DOI: https://doi.org/10.5731/pdajpst.2020.012567

Review

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    Overview of “The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products”
    Osamu Shirokizawa, Keisuke Inoue and Tsutomu Kamikukita
    PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 490-505; DOI: https://doi.org/10.5731/pdajpst.2018.009308

Commentary

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    A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug Products
    Dennis Jenke
    PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 506-535; DOI: https://doi.org/10.5731/pdajpst.2020.012617
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    A Commentary on Several Study Design Considerations Pertaining to the Screening of Substances Extracted and/or Leached from Pharmaceutical Contact Materials
    Steven A. Zdravkovic
    PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 536-552; DOI: https://doi.org/10.5731/pdajpst.2020.012624
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    Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality
    Gerald McDonnell, Hal Baseman and Lena Cordie-Bancroft
    PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 553-570; DOI: https://doi.org/10.5731/pdajpst.2021.012706
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 75 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 6
November/December 2021
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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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