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intervals around that data, and that's based on the variability of the products and the variability of our study.  Generally, for most products with normal levels of variability, say CVs of 25 percent or as much as 30 percent, the mean data or the point estimates that we see in normal bioequivalence studies don't generally fall outside of 10 percent and most of them are around 3 percent either way because essentially the confidence interval has a width around that mean and it doesn't really take much movement away from center to cause the edge of that confidence interval to go over our limit and fail.  So if you're really just talking about mean data, the means never really get a chance to get out anywhere close to the plus or minus 20 percent.

So the problems that we deal with or the issues, among others, are assay sensitivity which has been mentioned before, that if you do your study and you don't give the assay a high enough signal, then you have some problems with variability and inability to tell the difference between two products.  That's one of the reasons, say, for example, with levothyroxine that the original recommendations were for 600 micrograms.  So

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