Open AccessOriginal drugs and their generics: a problem of choice
Author(s) -
S. Yu. Martsevich,
С. Н. Толпыгина
Publication year - 2009
Publication title -
arterialʹnaâ gipertenziâ
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.126
H-Index - 5
eISSN - 2411-8524
pISSN - 1607-419X
DOI - 10.18705/1607-419x-2009-15-2-209-213
Subject(s) - bioequivalence , equivalence (formal languages) , medicine , computer science , mathematics , management science , pharmacology , engineering , pharmacokinetics , pure mathematics
The main distinctions of original and generic drugs are described, and the registration criteria of generics are given. The article considers the main causes of bioequivalence and therapeutic equivalence mismatch of original and generic medicines presenting several examples based on the results of clinical comparative studies, including Enalapril Maleate (comparison of original Renitec and generic Enam). The main approaches of planning the therapeutic equivalence comparative studies are offered.