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protection for the consumer of those marginal quality products, and I think that's a point regarding to the two questions.

What I'm trying to say is that we are not questioning the quality limiting approach, but we are setting up the question, what is the standard we want to put out for the setting up the quality control procedure?

DR. KIBBE:  Does anybody else have a comment?

MR. SCHUIRMANN:  Just to expand on what Dr. Tsong was saying.  Suppose that I'm a product manufacturer and I have a process that tends to produce batches of metered-dose inhalers that over the whole batch average about a 100 percent of label claim.  My process is on target, and my process tends to produce batches that have about a standard deviation of 11.  11 what?  11 percentage points of label claim.  So that's the measure of variability of the delivered dose from individual actuations of my product.

Well, if I start producing lots of batches and applying the FDA test as described in the guidance, I'm going to only be approving about a little more than 65 percent of my batches.  35 percent of my batches are going

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