Experts Probiotek fulfilled “turnkey” bioequivalence study of one of the first Russian of generic drugs melatonin.
The complexity of the study was the influence of endogenous melatonin concentration of the studied drugs in plasma. Therefore, we developed a special design that took into account the influence of power and lighting in the premises for the production of the body ‘ s natural melatonin.
The result has been to reduce the content of endogenous melatonin, which is 200 times compared to its concentration after administration of drugs.
In addition, to determine the substance in the blood experts of the bioanalytical laboratory “Probiotek” developed an original technique, which has helped to speed up the analysis by 30% and to finish the project early.
This approach allowed us to accurately and reliably estimate the concentration of exogenous melatonin on the basis of which were calculated pharmacokinetic parameters. The result was concluded that bioequivalence of the tested and reference preparations.
The Ministry of health adopted the report of the Group of companies “Probiotic” without comment, the drug was registered on and will soon appear in pharmacies.
Source: GK “Probiotic”