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In This Issue
Jump to section
- Article
- Abstract
- I. Introduction
- II. Definition and Origin of the Product Sterility Test
- III. Limitations and Shortcomings of the Product Test for Sterility
- IV. Case Study — Overreliance on Viability/Test for Sterility Results to Disposition Irradiated Anthrax Spores
- V. There Must Be a Better Approach — the History of the Parametric Release for Drug Products Terminally Sterilized with Moist Heat in the United States
- VI. Global Definitions of Parametric Release
- VII. Current Global Regulatory Status of Parametric Release
- VIII. Current State of Parametric Release—Summarized Results from PAT Moist Heat 2020 Survey
- IX. Use of Risk Assessment to Support Parametric Release Programs
- X. Summary/Conclusion
- Conflict of Interest Declaration
- Acknowledgment
- References
- Figures & Data
- References
- Info & Metrics