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PDA Journal of Pharmaceutical Science and Technology|May 15, 2021
A Safety Risk-Based Extractables and/or Leachables Qualification Strategy for Packaged Drug ProductsDennis Jenke
PDA Journal of Pharmaceutical Science and Technology|July 15, 2025
Automated Surface Swab Sampling: A Statistical Comparison of a Novel Approach to Existing MethodsNicole Collier, Michael Lund, Keith Bader, et al.
PDA Journal of Pharmaceutical Science and Technology|December 16, 2025
The European Qualified Person: Legal Accountability, Quality Leadership, and AI Integration in Modern Pharmaceutical ManufacturingMario Stassen
PDA Journal of Pharmaceutical Science and Technology|December 26, 2024
Leachables Analysis from a Closed Connected Single-Use mAb Purification ProcessAlfred Haglind, Emil Håkansson, Nils Wallménius, et al.
PDA Journal of Pharmaceutical Science and Technology|March 3, 2025
Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry SurveysSteven A Zdravkovic, Qiang Fu, Aaron Flick, et al.
PDA Journal of Pharmaceutical Science and Technology|March 3, 2025
A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)Kelly Waldron, Amanda McFarland, Hal Baseman, et al.
PDA Journal of Pharmaceutical Science and Technology|March 3, 2025
Visual Inspection of Topical Ophthalmic Formulations Packaged in Opaque and Semi-Transparent Containers: Working Towards Alignment with USP Visible Particulates in InjectionsMary Lee Ciolkowski, Ann T Davis, Alexa Harding, et al.
PDA Journal of Pharmaceutical Science and Technology|August 23, 2024
Ebeam Technology - Transfer Technology for Pre-Sterilized RTU ComponentsManfred Holzer
PDA Journal of Pharmaceutical Science and Technology|August 23, 2024
A Novel Combined Approach to Better Predict Sealing Performance of Luer Lock ConnectivityJulien Singer, Lucile Gontard, Yetirajendra Daroji, et al.
PDA Journal of Pharmaceutical Science and Technology|August 23, 2024
Comparison of Excipients in Approved Parenteral Products and Their Maximum Daily Exposure ValuesMiha Homar, Špela Kalčič, Gorazd Gorup
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