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PDA Journal of Pharmaceutical Science and Technology

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Published Ahead of Print

Each month, PDA Journal of Pharmaceutical Science and Technology publishes articles accepted for publication in advance to final issue designation, with the permission of the authors. Accepted Articles are the unedited, unformatted manuscripts that are accepted by the Editor-in-Chief following a successful peer-review. These drafts will be removed from Accepted Articles when the final and typeset version of record are published in an issue of the journal. 
 

To see an article, click its [PDF] link. To review many abstracts, check the boxes to the left of the titles you want, and click the 'Get All Checked Abstract(s)' button. To see one abstract at a time, click its [Abstract] link.

Case Studies

  • You have access
    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 February 2025, pdajpst.2024-003038; DOI: https://doi.org/10.5731/pdajpst.2024.003038
  • You have access
    Case Study: Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working towards alignment with USP<790> Visible Inspection of Injections
    Mary Lee Ciolkowski, Ann T. Davis, Alexa Harding and Stacey M. Platzer
    PDA Journal of Pharmaceutical Science and Technology February 2025, pdajpst.2024.003017; DOI: https://doi.org/10.5731/pdajpst.2024.003017

Commentary

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    A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
    Mariam Salamatian, Yvonne Gross, Magnus Stering, Thao Le Vinh and Ashira Bindels
    PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2024.012990; DOI: https://doi.org/10.5731/pdajpst.2024.012990
  • You have access
    Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
    Jennifer Anderson, Chelsea Burgwin and Donna Hamilton
    PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003024; DOI: https://doi.org/10.5731/pdajpst.2024-003024.1

Research Paper

  • You have access
    Coring and fragmentation of elastomeric needle shield in a pre-filled syringe
    Sahab Babaee, Sean Teller, Kavin Kowsari, Nikolaos Vasios, Steven C. Persak, Nagi Elabbasi and Guangli Hu
    PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003041; DOI: https://doi.org/10.5731/pdajpst.2024-003041.1
  • You have access
    Analysis of virus clearance for biotechnology manufacturing processes from early to late phase development
    Opeyemi O. Ajayi, Jackie L. Cullinan, Innara Basria, Madaisabel Fuentes-Arias, Ashley Osuna-Najarro, Sarah Johnson, Talia Faison and Scott Lute
    PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2025-000001; DOI: https://doi.org/10.5731/pdajpst.2025-000001.1
  • You have access
    Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot
    Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva
    PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003023; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1
  • You have access
    Preservative efficacy testing of refrigerated pharmaceuticals: choice of challenging isolate and storage temperature
    Seyed Sadeq Mousavi Ghahfarrokhi, Zeinab Zarei, Khadijeh Hamidian, Sepideh Nikrou, Mohammad-Reza Seidi, Hossein Jamalifar and Nasrin Samadi
    PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003021; DOI: https://doi.org/10.5731/pdajpst.2024-003021.1

Review

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    The Role of Microbiologists in Drug Product Development
    Donald C. Singer, Deborah D. Gross and Anthony M. Cundell
    PDA Journal of Pharmaceutical Science and Technology May 2025, pdajpst.2025-000010.1; DOI: https://doi.org/10.5731/pdajpst.2025-000010.1

Technology/Application

  • You have access
    Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
    Michael W Foubert, Benoit Lux, Julie Bourguard, Lucas Schultz, Meng John Zhao, Jason D Marlin, Matthew S Huser, Henri Hebting and Lei Li
    PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024.012941; DOI: https://doi.org/10.5731/pdajpst.2024.012941

Accepted Articles publish to this page on or about the 15th of each month.

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© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

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