MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....of each facility involved in the manufacturing of the drug substance and excipients should.....program because they can affect the ability of the product to deliver reproducible doses..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....associated acceptance criteria depend on the route of administration of the drug product.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=77)

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...2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry.....associated acceptance criteria depend on the route of administration of the drug product.....drug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=75)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=34)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...
...2 The general term product as used in this guidance means drug substance, drug product, and intermediate, or in.....including the analytical procedures that will be used, and acceptance criteria that will.....the drug substance, drug product, and/or, if appropriate, the intermediate, in-process material..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=32)

/a/content.30891
...using the criteria, what we have defined as the f2 criteria, 22.. which is a simulated.....rate and extent of drug absorption, its pharmacokinetics, 16.. pharmacodynamics, and the.....product for the first time without doing in vivo testing, 25.. and the answer to that is..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=23)

...One kind of valid drug claim is a claim related to the effect of the product on the.....The petitioner must demonstrate, among other things, that the use of the substance at.....The regulations also establish criteria for determining when a statement about a dietary..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=13)

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