PDA Journal of Pharmaceutical Science and Technology: 75 (6)

November/December 2021; Volume 75,Issue 6

Research

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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

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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

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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