MDI and DPI Drug Products
...distribution, crystallinity, dose content uniformity, microbial content, and stability.....stability test storage conditions. Additional studies should be performed to characterize.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...60 1 The test we have for dose content 2 uniformity or delivered dose uniformity for 3 inhalation products right.....11 In fact, the zero tolerance test is essentially the 12 USP test that is used for all content uniformity, 13 it is.....It is essentially a measurement of, it's 16 content uniformity, how much of the dose is 17 delivered in, let's say, a spray or..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.DOC (score=42)

...The first, dose content uniformity through container life, our working group has recommended.....One is you noted that there would be statistical comparisons between the lowest dose of test and.....The proposal is that for assessing efficacy, you would look at a single dose of the test versus..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.txt (score=13)

...The first, dose content uniformity through container life, our working group has recommended.....One is you noted that there would be statistical comparisons between the lowest dose of test and.....The proposal is that for assessing efficacy, you would look at a single dose of the test versus..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3764t1.htm (score=13)

stability guidance -draft
...when significant change in aerodynamic particle size distribution or in dose content uniformity.....Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human.....container meeting dose content uniformity, aerodynamic particle size distribution..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=13)

FDA Updates--July-August 2004 FDA Consumer
...Veterinarians will determine the initial treatment dose based on the dog's weight and then.....The FDA recently approved the use of oral fluid samples with a rapid HIV diagnostic test.....In addition, the agency is proposing to extend sodium content labeling requirements to OTC..
http://www.fda.gov/fdac/departs/2004/404_upd.html (score=13)

FR Doc 03-14140
...Evaluation of the Z values for the two 1-hour test days and the 24-hour test day showed that both products were.....At 24 months, this same ratio was found to increase only in the high-dose groups of both.....In addition, the monograph labeling follows the format and content requirements of Sec..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=5)

Document
...definition test, there was at least a 20- the last antiperspirant application. controlled.....agency doubts that any chromatographic identification or content test, and no .. Category.....Several other studies, middle-dose group and all the males .. showing that inhaled..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=5)

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