PDA Journal of Pharmaceutical Science and Technology: 78 (4)

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July/August 2024; Volume 78,Issue 4

Editorial

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2024 July/August Editorial
PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 384-385; DOI: https://doi.org/10.5731/pdajpst.2024.001844

Letter to the Editor

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Letter to the Editor
Tony Cundell

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 386-387; DOI: https://doi.org/10.5731/pdajpst.2024.013000

Research

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Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine
Thierry Gastineau, Cynthia Ban, Ana Basso, Franziska Brehme, Ana Luisa Silva, Olivier Faure, Lyne Le Palaire, Priya Persaud and Heraclio Rodriguez

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 388-398; DOI: https://doi.org/10.5731/pdajpst.2023.012850
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Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz and Lee Nagao

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 399-444; DOI: https://doi.org/10.5731/pdajpst.2022.012811
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Comparison of Excipients in Approved Parenteral Products and Their Maximum Daily Exposure Values
Miha Homar, Špela Kalčič and Gorazd Gorup

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 445-464; DOI: https://doi.org/10.5731/pdajpst.2022.012782
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Impact of NaCl on Monoclonal Antibody Aggregation Induced by Agitation
Justin K.Y. Hong, Wei Liu and Kai Zheng

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 465-474; DOI: https://doi.org/10.5731/pdajpst.2023.012860

Technology/Application

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Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Camellia Zamiri, Danielle L. Leiske, Patricia Hughes, J. Paul Kirwan, Evelyn Der, Emily Cox, Rob Warburton, Monica Goss, Sarah Weiser, Janet Perez-Brown, Ganapathy Gopalrathnam, Jing Liu, Shyam B. Mehta, Shebeer Shereefa, Sebastian Specht, Sandra J. Aedo, Pierre Goldbach, Feng Jia, Barbara Kuehnle, Scott Page, Liesbeth Voeten, Li Yi and Chen Zhu

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 475-500; DOI: https://doi.org/10.5731/pdajpst.2022.012806

Commentary

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Demonstrating Results Equivalence of Bacterial Endotoxins Test Methods
Steven Walfish, John Duguid and Karen McCullough

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 501-511; DOI: https://doi.org/10.5731/pdajpst.2023.012871

Poster Abstracts

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Case Study: Compatibility Testing of Pre-Filled Syringe Stopper Technology with Vaporized Hydrogen Peroxide Terminal Sterilization Process
Juha Mattila, Michael Kienzle and Arja Ruley

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 512-513; DOI: https://doi.org/10.5731/pdajpst.2024.012965
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A Novel Combined Approach to Better Predict Sealing Performance of Luer Lock Connectivity
Julien Singer, Lucile Gontard, Yetirajendra Daroji, Jimmy Voniez, Nestor Rodriguez, Diana Koschel and William Leverd

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 514-515; DOI: https://doi.org/10.5731/pdajpst.2024.012966
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Nonlinear Tissue Permeability Drives Tissue Pressure and Injection Distribution: A Computational Investigation of Subcutaneous Injections
Scott Lovald, Shashank Agarwal, Anuradha Radhakrishnan, Vincent Casey and Andrew Rau

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 516-517; DOI: https://doi.org/10.5731/pdajpst.2024.012969
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Finite Element Analysis of Skin Deformation and Puncture for Microneedle Array Design
Scott Lovald, Chris Berkey, Nikita Pak, Maysam Gorji and Andrew Rau

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 518-519; DOI: https://doi.org/10.5731/pdajpst.2024.012970
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Comparison of the Cobalt Content in Needles Stainless Steel
Laura Berardi

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 520-521; DOI: https://doi.org/10.5731/pdajpst.2024.012977
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Ebeam Technology - Transfer Technology for Pre-Sterilized RTU Components
Manfred Holzer

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 522-523; DOI: https://doi.org/10.5731/pdajpst.2024.012978
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Using Digital Instructions to Address on-Market Product Complaints and Improve User Experiences
Thomas Grant

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 524-525; DOI: https://doi.org/10.5731/pdajpst.2024.012979
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Evaluating Unmet Needs in Large-Volume Subcutaneous Drug Delivery: US Payer Perspectives on a Novel, Large-Volume On-Body Delivery System
Mehul Desai, James Kenney and Edmund Pezalla

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 526-527; DOI: https://doi.org/10.5731/pdajpst.2024.012980
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Reusable vs Single Use: what Are the Device Trade-Offs in Improving Sustainability
Alastair Willoughby

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 528-529; DOI: https://doi.org/10.5731/pdajpst.2024.012981
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Rethinking Human Factors in Obesity: Development of Simulation and Physical Test Models of Human Soft Tissue to Study Autoinjector Activation Performance
Eric Linvill, Chung Tsai, Paolo Ravaynia, Chun Chang, Karin Brolin, Victor Alvarez and Sofia Jonasson

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 530-531; DOI: https://doi.org/10.5731/pdajpst.2024.012993
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Prefilled Ophthalmic syringes - New Possibilities in Terminal Sterilization
Bernd Zeiss, Eric Offermann, Annick Gillet, Erik Haghedooren and Markus Bischof

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 532-533; DOI: https://doi.org/10.5731/pdajpst.2024.012968

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Parenteral Drug Association, Inc.