Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada

Laszlo Tothfalusi

Department of Pharmacodynamics, Semmelweis University, Budapest, Hungary


The Problem of Assessing the Bioequivalence of Highly-Variable Drugs

Qualitative Exposition of the Problem

The assessment of bioequivalence (BE) of highly-variable (HV) drugs has been of great concern over the past several years. The issue was repeatedly a principal topic at several conferences (1-3) and also at an American Association of Pharmaceutical Scientists (AAPS)/Food and Drug Administration (FDA) workshop (4) and at a recent AAPS symposium (5). Regulatory agencies have also been considering the problem, especially in recent years.