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FOOD AND DRUG ADMINISTRATION - page 103 / 263

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We could play with the numbers and you could eventually come to an amount where the zero tolerance feature would kick out that batch, but the parametric test would let it pass, and then the question is, if the content is low enough that you're in that zone, is that the type of content that would lead to an adverse reaction, and that's not something I can answer.

DR. HUSSAIN:  I think the point I'm making here is, I think, the thought process that this is a test.

DR. SADEE:  Yes, but we do have to consider the risk for each individual drug which is very different.

DR. HUSSAIN:  Definitely.

DR. SADEE:  -- be much more stringent, so we cannot talk about one standard.  You have to reflect that.

DR. HUSSAIN:  No.  That's a very good question, but I think when we talk about two different approaches, I think you have to look at how is this approach protecting that and how is that other approach protecting that.  What I would sort of suggest is with a rigorous statistical basis, the proposed test would protect it better.  So that's the point.

DR. KIBBE:  You had something to say?

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