Table of Contents

July/August 2024; Volume 78,Issue 4

  1. Page, Scott

    1. 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

  2. Pak, Nikita

    1. 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

  3. Palaire, Lyne Le

    1. 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

  4. Parris, Patricia

    1. 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

  5. Perez-brown, Janet

    1. 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

  6. Persaud, Priya

    1. 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

  7. Pezalla, Edmund

    1. 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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