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been addressed by IPAC-RS and Dr. Olsson will talk to these issues, but before I do that, I'd like to say that OPS is interested in implementing a parametric tolerance interval approach for dose content uniformity.  It places the test on a firm statistical basis and by that, I mean, it clearly states the allowable consumer risk; that is, an alpha of not more than 5 percent.  It clearly specifies a limiting quality standard.  It allows firms to control producer risk through selection of sample size and number of tiers of testing, and as proposed by IPAC-RS, it eliminates the zero tolerance criterion, and we know that the zero tolerance criterion represents a problem as n increases; as the sample size increases, there's more likelihood of finding a particular sample outside of that tolerance limit, and Dr. Hauck will describe that issue.

But for the above reasons that I just mentioned, we do view that should such a test be implemented, it would represent a win-win for both consumer and industry.

But I want to indicate that there are certain issues that remain to be resolved at this point, and we are simply bringing this topic to the advisory committee

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