EXPERT APPROACHES TO EQUIVALENCE EVALUATION OF DRUGS — ANALOGUES OF ENDOGENOUS COMPOUNDS AS CONSISTENT WITH THE RUSSIAN LEGISLATION AND INTERNATIONAL LAW

EXPERT APPROACHES TO EQUIVALENCE EVALUATION OF DRUGS — ANALOGUES OF ENDOGENOUS COMPOUNDS AS CONSISTENT WITH THE RUSSIAN LEGISLATION AND INTERNATIONAL LAW

The article demonstrates that bioequivalence studies of generic drugs whose active substances are analogues of endogenous compounds found in the human body in natural concentrations present a major challenge as compared to other products and call for a specific regulatory approach. In the absence of...

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Bibliographic Details
Main Authors: D. P. Romodanovsky, D. V. Goryachev, A. P. Solovieva, I. V. Kokin, N. N. Eremenko
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-03-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
bioequivalence
bioequivalence studies
comparative pharmacokinetic clinical studies in vivo
еndogenous compounds
еndogenous drugs
Online Access:https://www.vedomostincesmp.ru/jour/article/view/150

Internet

https://www.vedomostincesmp.ru/jour/article/view/150

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