Table of Contents

January/February 2025; Volume 79,Issue 1

  1. Agalloco, James

    1. Expanding the Use of Moist Heat for Terminal Sterilization
      James Agalloco
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 114-121; DOI: https://doi.org/10.5731/pdajpst.2023.012918

  2. Baseman, Hal

    1. A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
      Kelly Waldron, Amanda McFarland, Hal Baseman and Maik Jornitz
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 88-97; DOI: https://doi.org/10.5731/pdajpst.2024-003038.1

  3. Bielinski, Mary Kate

    1. Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
      Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 4-27; DOI: https://doi.org/10.5731/pdajpst.2024.012964

  4. Christiaens, Piet

    1. Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
      Dennis Jenke, Piet Christiaens and Ted Heise
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 98-113; DOI: https://doi.org/10.5731/pdajpst.2024.012945

  5. Ciolkowski, Mary Lee

    1. Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections
      Mary Lee Ciolkowski, Ann T. Davis, Alexa Harding and Stacey M. Platzer
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 59-67; DOI: https://doi.org/10.5731/pdajpst.2024-003017.1

  6. Davis, Ann T.

    1. Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP<790> Visible Particulates in Injections
      Mary Lee Ciolkowski, Ann T. Davis, Alexa Harding and Stacey M. Platzer
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 59-67; DOI: https://doi.org/10.5731/pdajpst.2024-003017.1

  7. Dessoy, Sandrine

    1. Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
      Mario Stassen, Catarina S. Leitão, Toni Manzano, Francisco Valero, Benjamin Stevens, Matt Schmucki, David Hubmayr, Ferran Mirabent Rubinat, Sandrine Dessoy and Antonio Moreira
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 68-87; DOI: https://doi.org/10.5731/pdajpst.2024.012950

  8. Eisele, Matthias

    1. Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
      Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas and Atanas Koulov
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 28-58; DOI: https://doi.org/10.5731/pdajpst.2024.012994

  9. Fedorowicz, Filip M.

    1. Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
      Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas and Atanas Koulov
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 28-58; DOI: https://doi.org/10.5731/pdajpst.2024.012994

  10. Flick, Aaron

    1. Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
      Steven A. Zdravkovic, Qiang Fu, Aaron Flick, Bhargava Jana, Elizabeth Looney, Samuel Kikandi, Tim Verdonck, Lee Nagao and Mary Kate Bielinski
      PDA Journal of Pharmaceutical Science and Technology January 2025, 79 (1) 4-27; DOI: https://doi.org/10.5731/pdajpst.2024.012964
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