title: Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products.
abstract: 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.
authors.affiliation: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA, richard.chang@fda.hhs.gov
authors.forename: Rong-Kun
authors.initials: RK
authors.lastname: Chang
authors.forename: Andre
authors.initials: A
authors.lastname: Raw
authors.forename: Robert
authors.initials: R
authors.lastname: Lionberger
authors.forename: Lawrence
authors.initials: L
authors.lastname: Yu
mesh_terms: D000287:Administration, Topical; D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000138:chemical synthesis / Q000592:standards*; D015195:Drug Design; D016568:Drugs, Generic / Q000138:chemical synthesis / Q000592:standards*; D006801:Humans
chemical_list: D003879:Dermatologic Agents; D016568:Drugs, Generic