MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....an internal reservoir containing sufficient formulation for multiple doses that are.....The guidance sets forth information that should be provided to ensure continuing drug..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

/a/content.30891
...slight changes in the formulation on product variability, 19.. because they may have made it the same way.....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..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=45)

antimicrobials general considerations
...the development of a specific antimicrobial drug product to facilitate product review, approval.....may be impossible to apply the criteria literally to each possible study scenario because.....This guidance document represents the Agency's current thinking on antimicrobial drug product..
http://www.fda.gov/cder/guidance/2580dft.pdf (score=78)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....CMC changes on the identity, strength, quality, purity, and potency of a specific drug product..
http://www.fda.gov/OHRMS/DOCKETS/98fr/protcmc.pdf (score=34)

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...formulation for a patient when a commercial pharmaceutical product is not available or.....the drug, that may occur as part of the pharmacological action of the drug or may be.....Establish criteria for the development and distribution of written prescription medicine..
http://www.fda.gov/cder/Offices/ODS/keystone.pdf (score=33)

Draft Guidance for Industry Comparability Protocols Protein Drug Products...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.....CMC changes on the identity, strength, quality, purity, and potency of a specific drug product..
http://www.fda.gov/cder/guidance/protcmc.pdf (score=33)

...One kind of valid drug claim is a claim related to the effect of the product on the.....The regulations also establish criteria for determining when a statement about a dietary.....Here, the principal issue is the claims made for a product rather than how the product is..
http://www.fda.gov/OHRMS/DOCKETS/98fr/010600a.txt (score=29)

...6 So, for this drug product obviously there will be 7 highly variable regardless of whether it.....19 Also, you can see that the switch-over 20 product, formulation B, again a 25 percent higher 21.....Also, that the point 25 estimate criteria be added to the criteria because, 72 1 in fact, all products will pass..
http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4034T2.DOC (score=29)

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