Bioequivalence studies are performed to demonstrate in vivo that two pharmaceutically
equivalent products (in the US) or alternative pharmaceutical products (in the EU) are …

This is a summary report of the EUFEPS & COST B25 conference on Bioavailability and
Bioequivalence which focused on physiological factors and variability. This conference was …

Purpose To explore the comparative performance of the recently proposed bioequivalence
(BE) approaches, FDA s and EMA s, by the FDA working group on highly variable drugs and …

Regulatory authorities introduced procedures in the last decade for evaluating the
bioequivalence (BE) for highly variable drugs. These approaches are similar in principle but …

In this article, the authors will briefly introduce the general concepts and background of
bioavailability and bioequivalence (BE), discuss the conventional method for BE …

In 2008, the European Agency for the Evaluation of Medicinal Products released a draft
guidance on the investigation of bioequivalence for immediate release dosage forms with …

The 2010 US Food and Drug Administration and European Medicines Agency regulatory
approaches to establish bioequivalence in highly variable drugs are both based on linearly …

This review starts with an introduction on the theoretical aspects of biopharmaceutics and
developments in this field from mid-1950s to late 1970s. It critically addresses issues related …

Purpose. The FDA Working Group on Highly Variable (HV) Drugs recently presented interim
procedures and conditions for determining the bioequivalence (BE) of HV drug products …

Purpose To develop and characterize new formulations of ziprasidone with a reduced food
effect achieved by increasing exposure in the fasted state. Methods Formulations were …