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- W2039057815 abstract "The degradation of a drug product over time must be studied carefully to determine the appropriate shelf-life of the product. It is desirable to use data from all batches of the drug product to estimate a common shelf-life. The current Food and Drug Administration Guideline for analyzing data from multiple batches in stability studies emphasizes hypothesis testing for assessing the equality of degradation rates among batches. We propose a definition for a meaningful difference in batch degradation rates. Furthermore, we use simultaneous confidence intervals for estimating differences in batch slopes and for making decisions about pooling data from separate batches. We believe that an estimation procedure based on simultaneous confidence intervals is philosophically and practically a better approach to this problem." @default.
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- W2039057815 date "1992-11-01" @default.
- W2039057815 modified "2023-09-23" @default.
- W2039057815 title "Multiple Comparison Procedures for Pooling Batches in Stability Studies" @default.
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- W2039057815 doi "https://doi.org/10.2307/1268945" @default.
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