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.....criteria that are numerical limits, ranges or other criteria for the tests described..
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.....Justification should be provided for all proposed acceptance criteria included in the drug.....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.....Justification should be provided for all proposed acceptance criteria included in the drug.....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=74)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....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Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....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=31)

/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.....release of the drug substance from the drug product and its.. 13.. absorption into the systemic..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=22)

...The petitioner must demonstrate, among other things, that the use of the substance at.....Because many of these claims would previously have been covered by the drug definition in.....The regulations also establish criteria for determining when a statement about a dietary..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=12)

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