A multiple-dose safety and bioequivalence study of a narrow therapeutic index drug: A case for carbamazepine

199917 citationsJournal Article

Authors

Avraham Yacobi · Rutgers, The State University of New Jersey

Steve Zlotnick · Université Laval

John L. Colaizzi · Albert Einstein College of Medicine

Daniel A. Moros · Rutgers, The State University of New Jersey

Eric Masson · Rutgers, The State University of New Jersey

Zohreh Abolfathi · Université Laval

Michel Lebel

Abstract

The multiple-dose study provided reliable safety and bioequivalence data under rigorous statistical conditions and confirmed bioequivalence of test and reference products determined by a single-dose study.

Topics & Keywords

Pharmaceutical studies and practices Statistical Methods in Clinical Trials Pharmaceutical Economics and Policy

UN Sustainable Development Goals

Good health and well-being

Publication Details

Published in: Clinical Pharmacology & Therapeutics

Volume 65, Issue 4, pp. 389-394

DOI: 10.1016/s0009-9236(99)70132-3

Field-Weighted Citation Impact: 2.51