Belarus will reduce the period of bioequivalence studies

| By | Belarus, Bioequivalence, EAEU

The information was announced by Alla Samson, Principal Investigator, Clinical Pharmacologist of the Clinical Research Department, National Anti-Doping Laboratory, a health authority.

This will become possible because all necessary stages of bioequivalence tests have been recently concentrated within the single site of National Anti-Doping Laboratory. It includes the development of clinical protocol, and clinical, analytical and biostatistical studies. Previously, these stages were held on different sites and, as a result, sometimes it took more than a year to obtain the final results. In addition, such logistics made the communication between the customer and contractor more complicated. Now that the specialists and necessary equipment are located at the same site, the time to obtain the final report will be significantly reduced.

According to Svetlana Pradun, Head of the Bioanalytical Research Department, there are several areas in Belarus where the development of protocol, and clinical, bioanalytical and statistical studies is implemented separately. Only the National Anti-Doping Laboratory concentrates them all in one place, which was done primarily for the benefit of customers, including both domestic and international pharmaceutical manufacturers. The results issued in the laboratory are valid in all EAEU member states.