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Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
Published on: November 24, 2021
Generic development of topical dermatologic products, Part II: quality by design for topical semisolid products
Rong-Kun Chang1, Andre Raw, Robert Lionberger
1Office 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
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.
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