Index by Author

July/August 2024; Volume 78,Issue 4

  1. Shereefa, Shebeer

    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. Silva, Ana Luisa

    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

  3. Singer, Julien

    1. 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

  4. Specht, Sebastian

    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

  5. Stanard, Brad

    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
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