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test, 65 percent of these hypothetical simulated batches were accepted, whereas with the PTI test, 95 percent of the batches were accepted, yet the coverage of these accepted batches is virtually the same at about 98 percent coverage.

Now, take a look here at the quality of the batches accepted by the FDA test and those rejected by the FDA test, and you will see that the quality is not that much different; whereas with the PTI test, there is a clear distinction in quality between those accepted by the test and those rejected by the test.  Now, this is due to the PTI test having a steeper OC curve being more efficient in discriminating between quality.

I'd also like to point out that with the 35 percent of the batches rejected by the FDA test, as you can see, this does not necessarily mean that the high rejection rate figure here, 35 percent, that these batches have been rejected due to poor quality.  Most of these batches have been rejected by the test because the test is not very discriminatory.  So it's a feature of the test that gives you the high reject rate.  These illustrations show that the gap is of lower relevance than perceived

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