Author(s): Shao J, Chow SC, Shao J, Chow SC
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Abstract In the pharmaceutical industry, some tests for quality assurance before, during and after the manufacture of a drug product involve a two-stage sampling technique. We propose statistical testing procedures in a two-stage sampling problem with large within-class sample sizes. We also derive a two-stage sampling plan by minimizing the expected squared volume (or the generalized variance) of the confidence region related to the test. We present two examples to illustrate the proposed methods.
This article was published in Stat Med
and referenced in Pharmaceutical Regulatory Affairs: Open Access