A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms
Nan‐Hung Hsieh, Frédéric Y. Bois, Eleftheria Tsakalozou, Zhanglin Ni, Miyoung Yoon, Wanjie Sun, Martin Klein, Brad Reisfeld, Weihsueh A. Chiu
Topics & Concepts
BioequivalencePharmacologyPopulationPharmacokineticsBupropionDosage formDissolution testingBioavailabilityPhysiologically based pharmacokinetic modellingDrugChemistryMedicineBiopharmaceutics Classification SystemPathologyEnvironmental healthSmoking cessationDrug Solubulity and Delivery SystemsCrystallization and Solubility StudiesStatistical Methods in Clinical Trials