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number of tests that these products must meet in order to be acceptable.  Another important one for aerosol products, in addition to the dose content uniformity, is the particle size distribution.  But it seems to me that very tight specifications could be set on a DCU test and yet tell us nothing about the goodness of the particle size distribution, and so I think they're independent tests.  So how does that fit into this issue?

And secondly, if we look at this 10 percent level as applying only to the parametric tolerance interval test, is there some way that we might be able to address this 10 percent issue in setting specifications on the parametric tolerance interval test?

With that, I'd like to stop and finish up with an acknowledgement slide, acknowledging Dr. Hussain, Dr. Poochikian, Mr. Schuirmann, Dr. Meiyu Shen, Dr. Yi Tsong, all from FDA, to acknowledge Dr. Walter Hauck, who's been involved with this issue when it was first raised under a contract that the agency had with Dr. Hauck, and lastly Dr. Roger Williams, who was the individual who back in 1998 had raised this issue when he was the OPS director and was looking at approaches that may be suitable for

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