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what we call the type II error, or beta error.  As variability is increased and you come into a region with unacceptably high variability, that is where you need your consumer protection, and ideally here, the acceptance probability should be 0 and deviations from this ideal 0, that is the type I error, or alpha error.

Now, as the curve transits from the high acceptance region to the low acceptance region, there is an area of uncertainty which is where the acceptance probability is neither good nor bad.  Of course, the steeper the curve, the smaller is this area of uncertainty.

This is a very important slide.  This shows the comparison between the PTI test curve for a sample size of 12/36 with the draft guidance test curve for multi-dose products.  Importantly here at 5 percent acceptance rate, which is the same to say 95 percent rejection probability, the two curves tie.  So they have the same consumer protection or, in other words, they have the same ability to reject quality of this type.

The PTI test is sharper.  It's more discriminatory, and that is why this curve is above that of the FDA curve in the producer protection region.  So

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