Bioequivalence and Therapeutic Equivalence of Psychotropic Drugs.

Abstract

Introduction to the market of generic drugs has increased access to modern therapies and enabled significant reduction of their cost, leading to containment of public expenditures on drug reimbursement. The assessment of bioequivalence of reference and generic drugs is based on the assumption that two different drug products are equivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of the present research was to retrospectively study therapeutic equivalence of selected reference and generic psychotropic drugs. In our preliminary data we show, that no significant differences in clinical outcome was observed in patients after the switch. It indicates, that bioequivalent drugs are also therapeutically equivalent and can be used interchangeably.