Generic therapy: the problem of choice

Abstract

The main differences between original and generic medications are discussed, and the criteria necessary for official generic registration are presented. The author describes possible reasons for bioequivalence and therapeutic equivalence discrepancy between original and generic medications, with enalapril maleate as an example of such discrepancies. Methodological approaches to designing comparative studies on medication therapeutic equivalence are presented.

Keywords

• оригинальные и дженерические препараты
• эналаприл
• биоэквивалентность
• терапевтическая эквивалентность
• сравнительные исследования