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FOOD AND DRUG ADMINISTRATION - page 100 / 263

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on slide 10, 90 percent within 80-120 would be under the blue curve.  It would match in the corners.  The blue curve is the bottom of the three curves.  So it would match in the corners but be lower in the center.

DR. ADAMS:  Dr. DeLuca, in addition to that, the 90 percent within 81 to 120 was a more recent suggestion that we had come up with subsequent to Dr. Hauck preparing his slides.  It gets to this issue of what Dr. Olsson called the gap which is the distance, the difference in standard deviation at a particular probability level between the FDA curve and the IPAC-RS curve and an interest on our part in trying to possibly move that operating characteristic curve for the IPAC-RS to the left, reducing the gap, and that's where that number was suggested.

DR. SADEE:  I can see the value of not having the limitation for production purposes.  On the other hand, I think that my question would be what is the risk of incurring an adverse event?  5 percent, for instance, would be unacceptable.  So if one goes further and further out of the range, then at what point is there a risk of an adverse reaction?  If there's too little in a metered

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