Multiple Comparison Procedures for Pooling Batches in Stability Studies (Q4029692)
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scientific article; zbMATH DE number 146326
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| English | Multiple Comparison Procedures for Pooling Batches in Stability Studies |
scientific article; zbMATH DE number 146326 |
Statements
1 April 1993
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stability studies
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bioequivalence
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indifference zone selection
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preliminary tests
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subset selection
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analysis of covariance
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FDA Guideline
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testing of the null hypothesis of homogeneity of the degradation rates
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simultaneous confidence intervals
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Multiple Comparison Procedures for Pooling Batches in Stability Studies (English)
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0.7777695655822754
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0.7396206855773926
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0.7329005002975464
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0.7259846925735474
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0.722931444644928
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Drug products are monitored for their stability over time. The method used for comparing \(k\) batches is the analysis of covariance. The FDA Guideline uses a method, which is based on testing of the null hypothesis of homogeneity of the degradation rates \((H_ 0: \beta_ i=\beta_ j\) for all \(i\neq j)\). The authors propose to examine simultaneous confidence intervals for \(\beta_ i-\min_{j\neq i}\beta_ j\), \(i=1,\dots,k\). Two examples illustrate the utility of the proposed procedure.
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