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deviations have been allowed because they have been necessary and well justified; otherwise they would not have been approved.  What we are saying is that this demonstrates that the capability of many products is not such that they can live with the current draft guidance curve.

Now, the PTI test provides a comparable reduction of consumer risk without compromising consumer protection, demonstrated by the fact that producer risk is reduced, whereas consumer protection is maintained.

As I said before, the point is that fewer rejections does not necessarily mean lower quality of accepted batches.  I will demonstrate that by showing you two cases of simulated or computer-simulated situations, one for unacceptable quality, where I'll show that the FDA and the PTI test have comparable performance in consumer protection, and the other case is for acceptable quality, where I'll show that the PTI test rejects fewer acceptable batches than the FDA test, yet the quality of those accepted batches are virtually the same.

Now, this is a busy slide.  I'll try to explain it to you.  First of all, each of the panels show

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