Specific features of the bioequivalence study of drugs - analogs of endogenous compounds

Abstract

This paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency, and Eurasian Economic Union’s approaches are discussed. The scientific literature on the bioequivalence studies of endogenous substances, as well as the results of clinical trial and marketing authorization applications assessments which were conducted by the FSBI “SCEEMP” in 2013-2015 are analyzed. General recommendations and principles for design and conduction of the bioequivalence studies of such medicinal products and reporting of their results are proposed, basing on the results of analysis of the foreign requirements, scientific data and domestic experience.

Keywords

• биоэквивалентность
• сравнительные фармакокинетические клинические исследования in vivo
• эндогенные соединения
• лекарственные препараты
• протокол клинического исследования
• евразийский экономический союз
• bioequivalence
• comparative pharmacokinetic clinical studies in vivo
• endogenous compounds
• drugs
• clinical research protocol
• the eurasian economic union