MDI and DPI Drug Products
...formulation, moisture level, consistency of filling operation, particle size distribution.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619.....the reproducibility of the dose and particle size distribution. Maintaining these..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)
FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Sophisticated and difficult-to-perform testing of MDI products, including particle size distribution, moisture content.....This interaction can contribute to inconsistent dose delivery and particle size.....Sophisticated and difficult to perform testing of DPI products, including particle size distribution, moisture content..
http://www.fda.gov/cder/fdama/difconc.htm (score=23)
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