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FOOD AND DRUG ADMINISTRATION - page 89 / 263

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I did want to throw this one in here just to assure you that the issue of maintaining the level of risk is not the structure or the form of the IPAC-RS proposal.  It really is just an issue of the choice of constants.  So there's really, if you will, a dose-dependency here.  You can change the constants.  They have what they call the f factor which limits the standard deviation.  So we have .8 here.  This is the IPAC proposal which has a value of just under .8 at the time, .8, coming down to .9, and then coming down to 1 which is the original regular tolerance interval.  I think you can see it's really just an issue of picking the constants right to maintain things appropriately.

So I thought I'd also summarize in terms of the IPAC proposal in terms of cost to sponsors because it's not all plus-plus.  It's not, you know, just gravy there, if you will.  First of all, as I indicated, for the most part, the sample sizes are going to be large, so there is an increased cost in that respect, and the details for the multi-dose products, there is a reduction in cost because rather than testing beginning, middle and end separately, it's combined into a single criterion.  

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