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Using tolerance intervals for assessment of pharmaceutical quality
Xiaoyu Dong1, Yi Tsong, Meiyu Shen
1a Office of Biostatistics , /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring , Maryland , USA.
Journal of Biopharmaceutical Statistics
|October 31, 2014
Summary
This study reviews tolerance intervals for drug quality control, detailing their statistical properties and application in ensuring product quality through one-sided and two-sided methods for various tests.
Area of Science:
- Pharmaceutical Quality Control
- Statistical Methods in Drug Development
Background:
- Tolerance intervals are crucial for drug product quality assurance.
- Acceptance intervals can be one-sided or two-sided based on quality attributes.
Purpose of the Study:
- To review computation methods for tolerance intervals.
- To study statistical properties of tolerance intervals regarding batch acceptance probability.
- To illustrate the application of one-sided and two-sided tolerance intervals.
Main Methods:
- Review of tolerance interval computation methods.
- Statistical analysis of batch acceptance probability.
- Application examples using dose content uniformity, delivered dose uniformity, and dissolution tests.
Main Results:
- Detailed review of tolerance interval calculation.
- Analysis of statistical properties impacting batch acceptance.
- Practical examples demonstrating one-sided and two-sided tolerance interval use.
Conclusions:
- Tolerance intervals are versatile tools for drug quality assurance.
- Understanding their statistical properties enhances their effective application.
- The study provides practical insights for quality control professionals.
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