RECENT CDER IMPACT STORIES

CDER is continuing to highlight its regulatory science research in a series of regulatory science impact stories. Recent posts include:

CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products Drugs delivered via transdermal patches are used to treat a wide variety of diseases and conditions, including high blood pressure, angina, hormone deficiencies, and depression. Statistical research at CDER has led to development of improved approaches for comparing the adhesion to the skin of generic transdermal drug products with that of brand name versions. These new approaches to performance testing help eliminate a major barrier to the availability of high-quality, well-adhering generic TDS products for patients.  Learn more

Modeling Tools Could Modernize Generic Drug Development  The term quantitative methods and modeling (QMM) in the context of drug development covers a broad spectrum of tools based on computational approaches and mathematical modeling. These tools combine to form the bases of “knowledge management systems” that integrate scientific understanding and existing data about drug products. Researchers at CDER’s Office of Generic drugs have recently developed a conceptual overview of how QMM can further generic drug development. Learn more.

CDER Assessment of Drug Impurity Mutagenicity by Quantitative Structure-Activity Relationship Modeling  The testing of the many low-level impurities present in some drug products for their ability to mutate DNA can be a significant burden for drug developers. CDER researchers are leading development of increasingly sophisticated and accurate computational models, including quantitative structure-activity relationship (QSAR) models, that can be used to predict the mutagenicity of these impurities. Learn more.