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A Two‐Way Analysis of Covariance Model for Classification of Stability Data
Author(s) -
Ahn Hongshik,
Chen James J.,
Lin TsaeYun D.
Publication year - 1997
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.4710390505
Subject(s) - type i and type ii errors , covariance , analysis of covariance , statistics , stability (learning theory) , monte carlo method , mathematics , computer science , algorithm , data mining , machine learning
This paper proposes a procedure for testing and classifying data with multiple factors. A two‐way analysis of covariance is used to classify the differences among the batches as well as another factor such as package type and/or product strength. In the test procedure, slopes and intercepts of the main effects are tested using a combination of simultaneous and sequential F ‐tests. Based on the test procedure results, the data are classified into one of four different groups. For each group, shelf life can be calculated accordingly. We examine if the procedure produces satisfactory control of the probability of a Type I error and the power of detecting the difference of degradation rates and intercepts for different nominal levels. The method is evaluated with a Monte Carlo simulation study. The proposed procedure is compared with the current FDA procedure using real data.