Analysis of the quality of bioequivalence and pharmacokinetics studies in Russia Federation

Autor: A. L. Khokhlov, E. G. Lileeva
Jazyk: ruština
Rok vydání: 2018
Předmět:
Zdroj: Качественная клиническая практика, Vol 0, Iss 2, Pp 64-70 (2018)
Druh dokumentu: article
ISSN: 2588-0519
2618-8473
Popis: In Russia the evaluation of bioequivalence of drugs for more than ten years the main requirement of medical and biological control of generic drugs. Regardless of manufacturer to the generic drugs are exactly the same as the original drug, must meet the following requirements: quality, efficiency and safety. In connection with the increase in recent years of bioequivalence studies of medicinal products requires careful control over the quality of these studies on the territory of the Russian Federation.
Databáze: Directory of Open Access Journals