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FDA Part of Generic Drug Bioinformatics Research

University of Florida researchers are working with CDER’s Office of Generic Drugs to develop an integrated bioinformatics approach to investigate potential claims of oral generic drug product bioinequivalence. A study report in the Journal of Clinical Pharmacology says that in the GDUFA 2012 letter of commitment, FDA committed to consult with industry and the public to create an annual list of regulatory science initiatives specific to research on generic drugs. The studies conducted under the initiative will advance the public health, the report says, by providing access to safe and effective generic drugs. It says the regulatory science results will provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products in all product categories.

The project involving the University of Florida Center for Pharmacometrics and Systems and FDA is intended to develop a mechanism- and risk-based strategy to evaluate reported postmarketing complaints about orally administered generic drugs. The strategy, starting with a patient or provider complaint, has three integrated components: (1) bioinformatics tools; (2) physiologically based absorption and pharmacokinetic models; and (3) population pharmacokinetic-pharmacodynamic models as well as bioinformatics approaches for benefit-to-risk ratio assessments.

“The significance of this research is that an integrated bioinformatics and pharmacometrics model-based strategy allows for a thorough risk-based evaluation of purported claims of bioinequivalence of generic drugs in the post-approval marketplace,” the report says.

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