Introduction Childhood systemic lupus erythematosus (cSLE) is a complex multisystem
autoimmune disease. In 2019, belimumab was approved for the clinical treatment for cSLE …

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

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology,
Second Edition explores statistics used in day-to-day clinical pharmacology work. The book …

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 …

The aim of this study was to develop a new in vitro–in vivo simulation (IVIVS) approach in
order to predict the outcome of a bioequivalence study. The predictability of the IVIVS …

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 …

Introduction Generic products of antiepileptic drugs (AEDs) are currently a controversial
topic as neurologists and patients are reluctant to switch from brand products to generics …

Purpose To verify previously reported findings for the European Medicines Agency's method
for Average Bioequivalence with Expanding Limits (ABEL) for assessing highly variable …

Generic drugs represent a significant portion of the medical arsenal in treating disease. As
copies of originator drugs, these drugs have been permitted abbreviated approval under the …