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.....The OTC drug review was designed to implement both the misbranding and the new drug.....In addition, the monograph labeling follows the format and content requirements of Sec..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.htm (score=100)

Document
...as safe and effective and not misbranded active ingredients in OTC drug products 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..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-14140.pdf (score=99)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....stability test storage conditions. Additional studies should be performed to characterize..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=53)

...I guess what concerns me is how do you really know, when you go from drug to drug and person to.....I should say in general the second test, although it's really a chronic irritation test.....If we look at all the secondary parameters with the exception of the dermal content, we..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3804t2.htm (score=49)

...The drug content of the test product cannot differ from that of the reference listed product by more than 5.....In BE studies, an applicant compares the systemic exposure profile of a test drug product to.....For ANDAs, we also recommend that the BE study be conducted between the test product and reference listed drug using the..
http://www.fda.gov/cder/guidance/5356fnl.doc (score=47)

Orange Book Preface
...the rate and extent of absorption of the test drug do not show a significant difference from.....The strength of parenteral drugs products is defined as the total drug content of the container.....the extent of absorption of the test drug does not show a significant difference from the..
http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm (score=46)

...0 Guidance for the Preparation and December 4, 1987 Do Do Content of Applications to the Food and Drug Administration for.....Aerodynamic Size Distribution Drugs of Abuse Screening Test Devices July 21, 1987 Do Do.....Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=32)

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