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In This Issue
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- Article
- Abstract
- 1. Introduction
- 2. Global Regulatory Expectations
- 3. Best Practices for Microbial Challenge In-Use Study Design and Execution
- 4. Interpretation of Microbial Growth and Assignment of In-Use Hold Time
- 5. Other Considerations
- 6. USP <797> and Sterile Preparations in Pharmacies
- 7. Conclusions
- Conflict of Interest Statement
- Acknowledgements
- References
- Figures & Data
- References
- Info & Metrics
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