RFA-FD-14-010: Characterization of Critical Quality Attributes for Semisolid Topical Dr... - 0 views
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MiamiOH OARS on 21 Mar 14To continue making safe and effective topical semisolid drug products available to the American public, it is essential that FDA's regulatory science, as well as best practices in the pharmaceutical industry, are informed by the most current understanding of the product quality attributes that are potentially critical to the therapeutic performance of topical semisolid dosage forms. The scope of this project is to characterize all measurable physical/chemical qualities of different dosage forms of semisolid topical drug products, identify appropriate methodologies for measuring each of these quality attributes, characterize formulation and manufacturing parameters that alter the arrangement of matter in the dosage form as measured by specific quality attributes, and utilize in vitro and/or in vivo measures of product performance to correlate variations in critical quality attributes with a failure mode for a drug product.