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as an awareness issue at this time.

The first one.  Dr. Hussain has spoken to this issue a few minutes ago when he indicated that the definition of limiting quality has not been resolved.  There are a number of choices, based upon this parametric tolerance interval approach.  One is the approach which IPAC-RS proposes.  That's the first bullet.  85 percent of the doses of the batch to fall within 75 to 125 percent of label claim.

But there are other definitions of limiting quality which could be used.  One is that 85 percent of the doses fall within 80 to 120 percent, a narrower range, of label claim.  Another is that even more samples, 90 percent of the doses could fall within 75 to 125 percent of label claim, or 90 percent of doses might fall within 80 to 120 percent of label claim.  And there may be other options for that.  But that is not a settled issue and that is one of the main issues that we continue to work with on this issue.

Another issue is robustness of the test.  There are questions for non-normally distributed data and, for instance, for short-tailed distributions, and I'm

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