Constructing Acceptance Limits for Multiple Stage Tests

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Abstract
Multiple stage tests are often used in the pharmaceutical industry (e.g., content uniformity, dissolution, disintegration). Acceptance limit methodology is given which assures that a future sample will have at least P% chance of passing a multiple stage test. For a given sample size, an associated acceptance region for the sample mean and standard deviation is found by (1) constructing a confidence region for the population mean and standard deviation, and (2) finding the probability of passing the test for each population mean and standard deviation in this confidence region. The acceptance region is the set of all sample means and standard deviations such that the probability of passing the test is greater than a specified P for all points in the confidence region.

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