Equivalence of Automated Test Procedures
Author Information
Author(s): K. Rick Lung, Mary A. Gorko, Jennifer Llewelyn, Norman Wiggins
Primary Institution: AstraZeneca Pharmaceuticals LP
Hypothesis
Can automated test methods be shown to be equivalent to manual test methods?
Conclusion
The Westlake Interval and Schuirmann's Two One-sided tests effectively demonstrate the equivalence of automated and manual test results.
Supporting Evidence
- The Westlake Interval showed equivalence for HPLC assay strength A with a mean of 99.94% for automated results.
- The Schuirmann's Two One-sided test confirmed equivalence for content uniformity with a calculated confidence interval within acceptable limits.
- Manual and automated results were equivalent for HPLC assay strength B with a mean difference of 0.68%.
Takeaway
This study shows that automated tests can be just as good as manual tests if we use the right methods to compare them.
Methodology
The study compared automated and manual test results using the Westlake Interval and Schuirmann's Two One-sided tests.
Potential Biases
Potential bias in the selection of methods and sample sizes.
Limitations
The study may not apply to tests with high variability or trace level measurements.
Participant Demographics
Results were obtained from proprietary tablet formulations tested by multiple operators.
Statistical Information
P-Value
0.05
Confidence Interval
0.47-1.09%
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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