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U.S. Department of Health and Human Services


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Product Quality Research

Product quality scientists in the Center for Drug Evaluation and Research conduct design of experiments to understand the impact on product quality attributes of changes in specifications of bulk drug substance and ingredients, formulation, packaging, manufacturing equipment and processes. These staff members also develop and assess physical, chemical and biological in vitro test systems and improved statistical and modeling procedures for the measurement or prediction of product quality attributes and bioavailability/bioequivalence determinations. These scientists plan and conduct research to evaluate safety, functionality and/or control of new excipients, vehicles and drug formulation, and delivery approaches.