Use of Partial AUC to Demonstrate Bioequivalence of Zolpidem Tartrate Extended Release Formulations |
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| Authors: | Lionberger Robert A. Raw Andre S. Kim Stephanie H. Zhang Xinyuan Yu Lawrence X. |
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| Affiliation: | (1) Office of Generic Drugs, Office of Pharmaceutical Science Center for Drug Evaluation & Research, Food & Drug Administration, 7519 Standish Pl., Rockville, Maryland 20855, USA |
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| Abstract: | ![]()
Purpose FDA’s bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modified-release dosage forms. Modeling and simulation studies were performed to aid in understanding the need for pAUC measures and also the proper pAUC truncation times. |
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