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FOOD AND DRUG ADMINISTRATION - page 112 / 263

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whatever rate, when you calculate out, it's really lower than 5 percent.  That means you release less than 5 percent for those you're supposed to release 5 percent.  There's also lots of work done that shows that if it's not under normal distribution, what is going to happen.

I think that if it's skewed, if it's skewed, but it's a uni-model, that means only one peak, have a distribution, even when it's skewed, it's pretty much robust on that.  But when the distribution is really widely different from normal, that could be totally different.

DR. KIBBE:  Ajaz?

DR. HUSSAIN:  Just to sort of put an overlayer of an engineering thought process there in a sense, because I do want to link that back to process understanding.  If you have a non-normal distribution in your samples and in your content uniformity, now, if that is related to your manufacturing run, is it happening in the beginning of the batch or in the end of the batch, and what is that?  I think that provides a level of understanding of process.  Is segregation occurring or whatever that mechanism is.  And I think this is what

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