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FOOD AND DRUG ADMINISTRATION - page 200 / 263

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versus 400.  The regulatory goal posts of 80 to 125 are shown in the yellow lines.  The magenta vertical line is unity.  Now, since we're comparing 450 versus 400 microgram doses, that appears right here, the blue line and it goes vertically.  So what we want to do is to look at how well the point estimate and the confidence interval center about this blue line because that's reality.

We're going to ask four questions of the methods that we looked at.  The first question is, will the method detect 25 percent differences, a rather large difference?

And then in the open session, many of the physicians said that, really, it's critical to be able to detect 10 or 12.5 percent difference in dose.  So what we have are three questions associated with that.  First, is 1.125 within the confidence interval?  Does it hit this blue line?  Second, is the difference between those two doses statistically significant?  And third, will the test fail that difference?

To go to the results, if you don't do any correction, then everything fails and there's really very little more to be said about that.

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