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

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

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 discuss...

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Bibliographic Details
Main Authors: V. K. Adonin, D. P. Romodanovskiy, R. R. Niyazov
Format: Article
Language:Russian
Published: NEICON ISP LLC 2018-02-01
Series:Ведомости Научного центра экспертизы средств медицинского применения
Subjects:
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
Online Access:https://www.vedomostincesmp.ru/jour/article/view/44

Internet

https://www.vedomostincesmp.ru/jour/article/view/44

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