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here that equals Y plus or minus kS, where we're defining Y, for dose content uniformity specifications, as being the absolute value of the difference between the label claim and the sample mean.  And my equation really should be slightly modified in that because I'm talking about an absolute value, it doesn't need that minus sign.  It should just be Y plus kS really, if we talk about the absolute value.

K is the tolerance interval constant.  The S is the sample standard deviation, and the acceptance value for this approach says that the acceptance value is less than or equal to Y plus or minus -- that is, Y plus or minus kS is less than or equal to the tolerance interval limits.  I think that will be a little clearer as we proceed.

A parametric tolerance interval test, based upon hypothesis testing, is intended to control the ranges of specified coverage; that is, it may say, for instance, 85 percent of the doses in the batch fall within 75 to 125 percent of label claim at 95 percent confidence, and therefore we're specifying some minimum proportion of the batch that should fall within the limits.  That's called

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