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and layers of approaches and then work that is done to eliminate that possibility.

MR. SCHUIRMANN:  I just wanted to add that looking now just at the dose content uniformity test as opposed to the whole battery of procedures that need to happen for a batch to be released, for the small version of the proposed test, 10 samples in the first tier and then 20 additional if you go to the second tier, if there were a single dose with zero content, then it would be impossible to pass the test, regardless of how the other observations came.

Now, I think this calculation could be done, and I apologize, I haven't done it.  If the sample sizes were larger, there could be a large enough set of sample sizes that there could be a single zero and it would still pass.  I can't tell you what that is.  I think the sample sizes would be very large indeed.

DR. KIBBE:  Jurgen?

DR. VENITZ:  I have two questions.  One is probably a stupid one, but what does IPAC-RS stand for?

DR. ADAMS:  It stands for International Pharmaceutical Aerosols Consortium for Regulation and

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