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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
