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the coverage.  We're specifying the acceptable tolerance limits, the target interval ‑‑ in this case 75 to 125 percent is shown ‑‑ and the degree of confidence.  That's an alpha level of 5 percent or less.

Now, a little bit of history in terms of these publications.  A tolerance interval approach is official in the Japanese Pharmacopeia for a variety of dosage forms unspecified.  That was based upon the work of the Japanese statistician Katori, et al., and it is now official.  It has been official since 1996.  The pharmacopeia discussion group which consists of representatives of the EP, the JP, and the USP, has published on this topic.  The Statistics Working Group of PhRMA has published on this topic.  They have three publications in the Pharmacopeia Forum, and ICH/PDG Task Force has published and in fact has the latest article in a year 2002 issue of the Pharmacopeia Forum.

All of those applications of the tolerance interval are not based upon hypothesis testing.

The first bullet here refers to a publication of Roger Williams, Guirag Poochikian, Walter Hauck and myself, published in 2002, Content Uniformity and Dose

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