MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....formulation, moisture level, consistency of filling operation, particle size distribution.....the reproducibility of the dose and particle size distribution. Maintaining these..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

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...As a rule, clinical trials supporting drug development. sensitivity of the overall.....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..
http://www.fda.gov/cder/guidance/91698.pdf (score=86)

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...of drug effect size can be well supported by reference to the results of previous studies.....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..
http://www.fda.gov/cder/guidance/4155fnl.pdf (score=84)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect.....This interaction can contribute to inconsistent dose delivery and particle size.....Metered dose inhalers are sophisticated drug delivery systems that require extensive development to ensure dosing accuracy..
http://www.fda.gov/cder/fdama/difconc.htm (score=84)

GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES...
...For example, in a filed process it was determined that particle size would have no effect on drug absorption and.....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..
http://www.fda.gov/ora/inspect_ref/igs/solid.html (score=80)

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