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net; and then the limit on the sample mean.

So one of the issues that has been raised regarding the FDA proposal is in front of you.  The idea is that what you're looking at is something that very much looks like a statistical hypothesis test.  You collect some data.  You perform a statistic.  If the statistic satisfies certain criteria, you say pass, and if it doesn't, you say fail, and the only thing missing from it is the hypothesis.  So there's no statement of what constitutes an acceptable batch, and this is what Dr. Adams was referring to.

So the focus, in effect, on the FDA proposal has been on what's an acceptable sample and not on what's an acceptable batch.  And I think the original issue raised is to say that seems kind of backwards and inappropriate, that the FDA's role should be to specify what's an acceptable batch and then the sponsor should then get to decide what sample they want to take.

So what IPAC-RS does is it essentially accepted that challenge and, as you've been hearing, they set down a specification referred to in the two previous talks as the limiting quality standard.  They propose the

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