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target.  And here's a plot to show the acceptance probability versus the batch mean for a number of sample sizes, and this shows that only for batch means at around 9 percent deviation from the target does the type I error at the limiting quality approach or slightly exceed 5 percent.  So this addresses one of the issues.

The other issues are listed here, and I will spend the remainder of my presentation going through the bolded points here.

Just a quick note on representative sampling.  This is an issue that is as important for any test whatsoever and has nothing specifically to do with the PTI test.  And IPAC-RS, we do absolutely agree that representative sampling is a necessary prerequisite for any test.

Also a quick note on the topic of differences between product types, to tell you that with the PTI test where the sample size can be adjusted without compromising consumer protection, this test is well suited to take care of differences between different product types yet having a consistent standard.

We've had several meetings with the agency to

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