Abstract
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.
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