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outside or above the red line here, the probability that that batch would actually pass whatever the rule ends up being.  And the producer risk, the converse of that, is that a batch that falls under the red line and meets the specification set, the probability that that batch fails.  Now, normally in trying to design studies, we always like both those probabilities to be small.  That's always the goal of study design.

Now, I should mention here that, as has been alluded to, that the issue of what that limiting quality should be is clearly on the table, and the type I/type II errors are going to very strongly depend on what that choice is.  Just to give you a bit of a flavor for that, Dr. Adams had put up some of the alternate choices that at least conceptually could be considered, and this just shows you what happens to that definition of acceptable batches, if you tighten up the IPAC-RS proposal which is the red line going down to keeping the 75-125 but changing the content to 90 percent, which is your green curve, or keeping the content but tightening the limit, the blue curve.  You can see a pretty substantial drop, particularly here at the top, in terms of the variability.

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