MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....program because they can affect the ability of the product to deliver reproducible doses..
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.....4 As the product comes out, we can measure 5 the moisture content as the product is being dried 6 and.....2 That is the whole concept behind the 3 delivered dose uniformity, that the product has to 4 have some consistent..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T1.DOC (score=42)

stability guidance -draft
...when significant change in aerodynamic particle size distribution or in dose content uniformity.....provided as part of the drug product specifications for the chemical content of.....container meeting dose content uniformity, aerodynamic particle size distribution..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=13)

...An adverse reaction is a noxious and unintended response to any dose of a drug product for which there is.....Implementation of Proposed Content and Format Revisions to Products Approved or Submitted.....All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug..
http://www.fda.gov/OHRMS/DOCKETS/98fr/122200a.htm (score=4)

IND content and format for Phase 1 studies
...As clinical development of a drug product proceeds,sponsors should discuss the.....exclusions; and a description of the dosing plan, including duration,dose, or method to be.....and the general requirements for an IND's content and format. III. CLARIFICATIONS OF..
http://www.fda.gov/cder/guidance/phase1.pdf (score=4)

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