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
About the Authors
V. K. Adonin
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
D. P. Romodanovskiy
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
R. R. Niyazov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
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Review
For citations:
Adonin V.K., Romodanovskiy D.P., Niyazov R.R. Specific features of the bioequivalence study of drugs - analogs of endogenous compounds. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(3):3-7. (In Russ.)
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