On April 6, 2021, Vasyl Petrus defended the thesis on the topic "Organization of analytical procedure transfer at a pharmaceutical enterprise" for the degree of Doctor of Philosophy (PhD) (scientific advisor – Dmytro Leontiev, Doctor of Pharmaceutical Sciences, Senior Researcher). The work was carried out at State Enterprise "Ukrainian Scientific Pharmacopeial Center for Quality of Medicines", National Pharmaceutical University and PJSC SIC "Borshagivskiy CPP".
The work is a further development of the scientific direction on applying the uncertainty concept of analysis results for quality assurance of medicinal products that State Enterprise "Ukrainian Scientific Pharmacopeial Center for Quality of Medicines" has been advancing over the past 20 years.
A distinctive feature of the work is that it is the first defended thesis in Ukraine, in which metrological approaches to ensuring the quality of analytical procedures are being developed as an integral part of the validation of technological processes.
The developed approach considers the factors of inhomogeneity of solid dosage forms and combines the advantages of the life cycle approach proposed by the USP and the metrological system of the State Pharmacopoeia of Ukraine, which formulates the acceptance criteria for the uncertainty of the analysis results based on the risk of obtaining an incorrect conclusion on compliance with the specifications.
The staff of State Enterprise "Ukrainian Scientific Pharmacopeial Center for Quality of Medicines" congratulates Vasyl Petrus and his scientific adviser Dmytro Leontiev and wishes them further scientific achievements!
