Assessment of Prescribability and Switchability by Using Multiple Bioequivalence Assessment Approaches

Conclusion: A single dose of MTX test met the ABE criteria of 80.00% -125.00% for Cmax, AUCo- t, and AUC0-∞, against MTX reference. The study outcome by PBE and IBE approaches proved that MTX Test was bio-inequivalent to MTX reference. Using multiple BE assessment methods in a single BE study is a novel approach and may overcome shortcomings of conventional bioequivalence assessment methods.
Source: Drug Metabolism Letters - Category: Drugs & Pharmacology Source Type: research