On stability designs in drug shelf-life estimation.
In this paper, various stability designs, including matrixing and bracketing designs for determining drug shelf-life, are considered. We propose a criterion for design selection based on the precision of drug shelf-life estimates. For a fixed sample size, it is recommended that the design with the best precision for estimating the shelf-life should be used. For a fixed desired precision, the design with the smallest sample size is the best choice of design. An example is presented to illustrate the proposed method.
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Department of Statistics, National Chengchi University, Taipei, Taiwan, Republic of China.
Chow
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SC
D004355:Drug Stability; D004356:Drug Storage; D007700:Kinetics; D008954:Models, Biological; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration