On the estimation of variance components in stability analysis |
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| Authors: | Chow Shein-Chung Wang Song-Gui |
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| Affiliation: | 1. Biostatistics Department , Bristori-Myers Squibb Co. , 777 Scudders Mill Road, Plainsboro, NJ 08536;2. Mathematics Department , University of Technology &3. Sciences of China , Hefei, Anhui, 230026, PRC |
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| Abstract: | Chow and Shao (1989, 1991) indicated that the presence of batch-to-batch variation has an impact on the determination of drug shelf-life in stability studies. In this paper, we propose two unbiased estmators for batch-to-batch variation. The proposed estimators are compared in terms of their corresponding variances. An example concerning a stability study is discussed to illustrate the use of the proposed estimators. |
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| Keywords: | Batch-to-batch variation Drug shelf-life stability variance component |
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