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Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for

Lei Miao1, Youssef M Mousa1, Liang Zhao1

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.

The AAPS Journal
|August 12, 2020
PubMed

Keywords:
bioequivalencedissolutionoseltamivirpediatricphysiologically based pharmacokinetic absorption model

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