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FOOD AND DRUG ADMINISTRATION - page 102 / 263

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right one, but I think the answer, I think I would like to sort of propose is, what happens today and what happens with the current FDA test and what happens with the PTIT?  There's no difference.

If there is a canister which is 0, has not content in it, what is the probability of finding that with the small sample size that we test today?  When it happens with the PTI test, it's going to be caught anyway.

MR. SCHUIRMANN:  Well, there's nothing much more to explain.  Dr. Hussain is particularly talking about a zero content canister, one that somehow didn't get any drug in it.  I assume that the adverse reaction you're worried about would come on the opposite end of the spectrum of it has too much in it.

If there's a canister lurking out there with 200 percent of label claim in it, the chance that it will end up in your tested sample is the same, no matter whose test you're using, the FDA draft test or the proposed parametric test.  If a canister with 200 percent of label claim actually did show up in the sample, I suspect that it would cause either test to reject the batch.

Now, I've picked 200 percent out of the air.  

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