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FOOD AND DRUG ADMINISTRATION - page 83 / 263

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acceptable really becomes the problem of the sponsor and not the problem of the agency because they get to choose the sample size.

I thought it might be useful for you to see a little bit of the difference between what -- I think there sometimes seems to be confusion going back and forth between batch and sample.  So this is just intended to highlight for you, the red curve again being what defines an acceptable batch and the green ‑‑ I guess I'll call it a curve but a pentagon or hexagon there ‑‑ is samples that satisfy the 2001 IPAC proposal of sample size of 30.  You can see it's substantially inside the red curve.

The second issue I wanted to talk about that has been raised regarding the draft guidance is that the FDA is fixing the sample size and any time the regulatory agency fixes the sample size, it's really denying the sponsor an opportunity to control their own producer risk.

So the IPAC-RS proposal does provide a choice of two-tier designs and, as you heard from Dr. Olsson's presentation, all of which are intended to maintain the false positive rate of 5 percent for each possible sample

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