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presentation, the current test specifies what constitutes an acceptable sample, but it does not indicate what constitutes an acceptable batch.

Now, there are two guidances which are appropriate to this topic.  One is the Metered Dose Inhaler and Dry Powder Inhaler Drug Products-CMC documentation draft guidance issued in 1998, and then a second guidance, the Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products-CMC documentation.  That's a final guidance and that was published in July of 2002, and both of those guidances cover dose content uniformity recommendations.

Now, this slide is simply a nomenclature slide to indicate that the first guidance, the MDI and DPI guidance, refers to dose content uniformity and the nasal spray guidance refers to spray content uniformity.  Uniformity of metered doses from an MDI, DPI or nasal spray considers performance within a container for multiple-dose products, among containers, and between batches.

The present DCU and SCU tests are essentially nonparametric tests, but they do have a parametric

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