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Minimal Erythema Dose MED Testing
Published on: May 28, 2013
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Statistical Properties of Large Sample Tests for Dose Content Uniformity.
Meiyu Shen1, Yi Tsong1, Xiaoyu Dong1
11 Division of Biometrics VI, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Therapeutic Innovation & Regulatory Science
|September 21, 2018
Summary
The European Union
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Statistics
Background:
- The European Pharmacopoeia (Ph. Eur.) 7.7 (2012) introduced a test for uniformity of dosage units for large sample sizes.
- Two alternative methods, EU Option 1 (parametric) and EU Option 2 (nonparametric), were proposed.
- Existing methods have limitations in evaluating dose content uniformity with large sample sizes.
Purpose of the Study:
- To evaluate and compare the acceptance probabilities of the two EU options and a proposed parametric method for dose content uniformity.
- To analyze the performance of these methods concerning batch mean and batch standard deviation.
- To extend a parametric method for dose content uniformity testing to large sample sizes.
Main Methods:
- Simulation studies were conducted to compare the acceptance probabilities of EU Option 1, EU Option 2, and the proposed parametric method.
- The proposed method is an extension of a parametric two one-sided tolerance interval-based approach for large sample sizes.
- Analysis focused on acceptance probabilities relative to batch mean and batch standard deviation under normality assumption.
Main Results:
- Both EU Option 1 and EU Option 2 demonstrated higher acceptance probabilities when the batch mean deviates from the target.
- Under normality, EU Option 2 showed a greater acceptance probability at a mean of 102% label claim compared to 100% label claim for a given standard deviation.
- The proposed method extends a previously developed parametric approach to accommodate large sample sizes.
Conclusions:
- EU Options 1 and 2 offer increased acceptance probabilities for off-target batch means in dose content uniformity testing.
- The study provides a comparative analysis of different methods for assessing dose content uniformity with large sample sizes.
- The proposed parametric method offers a viable alternative for large-scale dose content uniformity evaluations.
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