Darnitsa Conducts Studies in EU Laboratories02 October 2020
During 2018-2020, Darnitsa has completed 8 bioequivalence studies of drugs for the treatment of cardiac and central nervous system diseases, the vast majority of which were conducted in the EU. Such studies are conducted by the company in order to prove the therapeutic equivalence and safety of generic drugs.
A generic medicinal product, apart from its conformity by the active substance, must be bioequivalent to the original drug. Compliance with this condition means the identical therapeutic effect, safety profile and tolerability of the generic.
Dmytro Shymkiv, Chairman of the Board of Directors of Darnitsa Group: “We are responsible to patients, and in order to be sure of the efficacy and safety of our drugs, we conduct the bioanalytical part of the studies in EU laboratories. When choosing partners - clinical bases and certified bioanalytical laboratories, we first of all pay attention to whether they can ensure the conduct of the studies at the appropriate quality level, in accordance with international requirements.”
As a rule, the clinical part of the studies is conducted by Darnitsa in Ukraine, after which it transfers biological materials to European laboratories for the final analysis. In particular, Darnitsa has long been cooperating with one of the best medical and bioanalytical centers in Europe, QUINTA-ANALYTICA s.r.o. (Czech Republic).