A Proposal for Alternative FDA Bioequivalence Criteria for Narrow Therapeutic Index Drug Products to Support Future Harmonization

Browse Research Outcomes

Author/s:Sun, Wanjie; Schuirmann, Donald; Makhlouf, Fairouz; Donnelly, Mark; Jiang, Wenlei; Zhang, Hongling; Mehta, Mehul U; Zhang, Lei; Tampal, Nilufer; Grosser, Stella

Date:01/01/2025

Journal:Pharmaceutical Research

DOI:10.1007/s11095-025-03915-2