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PDA Journal of Pharmaceutical Science and Technology

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Table of Contents

September/October 2020; Volume 74,Issue 5

Guest Editorial

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    Scientific Studies and Interpretation
    Edward C. Tidswell and James Akers
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 495-496; DOI: https://doi.org/10.5731/pdajpst.2020.012302

Research

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    NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
    Jennifer L. Mantle and Kelvin H. Lee
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 497-508; DOI: https://doi.org/10.5731/pdajpst.2019.011049
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    Test Process and Results of Potential Masking of Sterilizing-Grade Filters
    Stephanie Ferrante, Leesa McBurnie, Mandar Dixit, Brian Joseph and Maik Jornitz
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 509-523; DOI: https://doi.org/10.5731/pdajpst.2019.011189
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    Data Mining to Determine the Influence of Fluid Properties on the Integrity Test Values
    Brian Thome, Brian Joseph, Dawood Dassu, Jeff Gaerke, Leesa McBurnie, Mandar Dixit, Magnus Stering, Sean Tomlinson, Scott Mills, Stephanie Ferrante and Carl Weitzmann
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 524-562; DOI: https://doi.org/10.5731/pdajpst.2019.011387

Case Study

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    Risk-Based Approach for Analytical Comparability and Comparability Protocols
    Kavita Ramalingam Iyer and Isabelle Lequeux
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 563-570; DOI: https://doi.org/10.5731/pdajpst.2019.010439

Review

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    Investigating Aberrant Results in Microbiological Examination of Nonsterile Product Assays
    Crystal Booth
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 571-580; DOI: https://doi.org/10.5731/pdajpst.2019.010504

Commentary

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    Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
    Wen-Li Chung, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Ann Woys, Rod Rahimi, Marianne Azarias, Connie Kong and Bruce Kabakoff
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 581-591; DOI: https://doi.org/10.5731/pdajpst.2019.010652
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    Probable Scenarios of Process Contamination with Cutibacterium (Propionibacterium) acnes in Mammalian Cell Bioreactor
    Angel L. Salaman-Byron
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 592-601; DOI: https://doi.org/10.5731/pdajpst.2019.010710

PDA Paper

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    Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
    Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
    PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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