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Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products

Fang Wu, Youssef M. Mousa, Rebeka Jereb, Hannah Batchelor, Sumon Chakraborty, Tycho Heimbach, Ethan Stier, Filippos Kesisoglou, Sivacharan Kollipara, Lei Zhang, Liang Zhao

2024The AAPS Journal13 citationsDOI

Topics & Concepts

Physiologically based pharmacokinetic modellingSession (web analytics)BioequivalenceRegulatory scienceComputer scienceNew product developmentAgency (philosophy)Best practiceFood and drug administrationManagement scienceProduct (mathematics)StructuringRisk analysis (engineering)Process managementEngineeringMedicinePharmacologyBusinessPharmacokineticsPolitical scienceMarketingSociologyFinanceSocial scienceLawGeometryWorld Wide WebPathologyMathematicsDrug Solubulity and Delivery SystemsPharmaceutical studies and practicesStatistical Methods in Clinical Trials
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products | Litcius