Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
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PDA J Pharm Sci Technol. 2023 Oct 17:pdajpst.2022.012806. doi: 10.5731/pdajpst.2022.012806. Online ahead of print.
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PMID: 37848203