Guidance for Review Staff and Industry: Good Review Management Principles...
...sample size, dose response, assessment of drug-drug ..interactions, demographic..
http://www.fda.gov/cber/gdlns/reviewpdufa.pdf (score=100)

FDA Consumer Reprint--Avoiding Problems Liquid Medication and Dosing Devices
...FDA has received reports about people misreading the markings on dose cups, using the wrong size dose cup from a different.....In 1992, FDA received a report of a child who had been given three times the safe dose of.....size), and tablespoons commonly used to measure doses. Common tableware teaspoons come in..
http://www.fda.gov/fdac/reprints/drugdose.html (score=100)

Guidance for Review Staff and Industry: Good Review Management Principles...
...sample size, dose response, assessment of drug-drug interactions, demographic differences), and..
http://www.fda.gov/cber/gdlns/reviewpdufa.htm (score=100)

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...to stop a study if the survival of only the low-dose group and/or the medium-dose group is.....of the animals, sample size, dose selection, method of allocation of animals, route of.....using a series of increasing dose levels, statistical tests for positive trends in tumor..
http://www.fda.gov/cder/guidance/815dft.pdf (score=100)

Statistical Aspects of the Design, Analysis, and Interpretation of Chronic...
...For example, there is no reason to stop a study if the survival of only the low-dose group and/or the medium-dose group.....size, dose selection, method of allocation of animals, route of administration, animal.....skin tumor reaching some prescpecified size) rather than the time or cause of the animal's..
http://www.fda.gov/cder/guidance/815dft.htm (score=100)

MDI and DPI Drug Products
...formulation, moisture level, consistency of filling operation, particle size distribution.....the reproducibility of the dose and particle size distribution. Maintaining these.....emitted dose content uniformity, particle size distribution, microscopic evaluation, 1619..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=39)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...This interaction can contribute to inconsistent dose delivery and particle size.....These interactions can contribute to inconsistent dose delivery and particle size.....Minor changes in the concentration or dose of an excipient can result in markedly..
http://www.fda.gov/cder/fdama/difconc.htm (score=34)

Document
...treatment effects nor unblinding of data and, sample size for the trial. guideline and the.....the dose of the active comparator, eligibility.. investigation of the shape and location.....be detected or rejected at the dose and in the.. investigational product is less than that..
http://www.fda.gov/cder/guidance/91698.pdf (score=34)

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...design that could unfairly favor one treatment are choice of dose or patient population.....smallest effect size that the active drug would be reliably expected to have is only.....used at too low a dose or whether the apparently less well-tolerated treatment has been..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=32)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...Although many firms evaluate dose uniformity using the compendial dose uniformity.....The size and even the type of granule can affect the pore size in a tablet and have an.....Different tablet compression equipment can cause dose uniformity, weight uniformity and..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=31)

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