Scientific Publications by FDA Staff

AAPS J 2013 Jul;15(3):674-83

Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products.

Chang RK, Raw A, Lionberger R, Yu L

The emergence of quality by design as a relatively new systematic science and risk-based approach has added a new dimension to pharmaceutical development and manufacturing. This review attempts to discuss the quality by design elements and concepts applied for topical semisolid products. Quality by design begins with defining a quality target product profile as well as critical quality attributes. Subsequently, this is followed by risk identification/risk analysis/risk evaluation to recognize critical material attributes and critical process parameters, in conjunction with design of experiments or other appropriate methods to establish control strategies for the drug product. Several design-of-experiment examples are included as practical strategies for the development and optimization of formulation and process for topical drug products.