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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.
PDA J Pharm Sci Technol. 2024 Aug 23;78(4):475-500. doi: 10.5731/pdajpst.2022.012806.
PDA J Pharm Sci Technol. 2024.
PMID: 37848203
Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing.
Weber J, Hauschild J, Ijzerman-Boon P, Forng RY, Horsch J, Yan L, Prasad A, Henry RB, Claassen M, Villari P, Shereefa S, Wyatt J, Bolden JS, Pycke JT, Dassu D.
Weber J, et al. Among authors: shereefa s.
PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):121-134. doi: 10.5731/pdajpst.2018.008722. Epub 2018 Oct 25.
PDA J Pharm Sci Technol. 2019.
PMID: 30361285
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Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations.
Prasad A, Milling A, Hauschild J, Ruh AC, Horsch J, Weber J, Yan L, Plourde L, Claassen M, Villari P, IJzerman-Boon P, Forng RY, Henry RB, Portmann R, Shereefa S, Urwyler S, Dassu D.
Prasad A, et al. Among authors: shereefa s.
PDA J Pharm Sci Technol. 2020 May-Jun;74(3):318-323. doi: 10.5731/pdajpst.2019.009969. Epub 2019 Dec 16.
PDA J Pharm Sci Technol. 2020.
PMID: 31843986
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