The section presents the latest significant scientific papers on reference standards, validation, and metrology published by the staff of State Enterprise “Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines” in peer-reviewed journals.

 

  • Volovyk, N., Leontiev, D., Petrus, V., Gryzodub, O., & Pidpruzhnykov, Y. (2020). Development of an advanced strategy on the assay method transferScienceRise: Pharmaceutical Science6 (28), 56-67. doi:http://dx.doi.org/10.15587/2519-4852.2020.221721
  • Leontiev, D., Petrus, V., Volovyk, N., & Gryzodub, O. (2020). VALIDATION OF THE SPECTROPHOTOMETRIC PROCEDURE FOR DESLORATADINE ASSAY IN TABLETS APPLYING THE UNCERTAINTY CONCEPT OF THE STATE PHARMACOPOEIA OF UKRAINEEUREKA: Health Sciences, (6), 74-87. https://doi.org/10.21303/2504-5679.2020.001527
  • Leontiev, D., Petrus, V., Volovyk, N., & Gryzodub, O. (2020). A study of the influence of the test sample inhomogeneity on variability in assay results of desloratadine in film-coated tabletsScienceRise: Pharmaceutical Science5 (27), 43-51. doi:http://dx.doi.org/10.15587/2519-4852.2020.215287
  • Gryzodub, O. I., Petrus, V. V., Leontiev, D. A., & Volovyk, N. V. (2020). Application of analysis of variance and regression for the assessment of technological variability in the manufacture of dipyridamole tablets. Farmacom, 1/2, 24-36.
  • Petrus, V. V., Leontiev, D. A., Volovyk, N. V., & Gryzodub O. I. (2019). A technological variation forecast in the industrial production of desloratadine tablets. Farmacom, 1/2, 37-47.
  • Leontiev, D. A., Volovyk, N. V., Bevz, O. V., Vashchenko, O. V., & Gryzodub, O. I. (2018). Characterization of a reference standard for qualification of differential scanning calorimetry intended for purity determination in certification of pharmaceutical reference standards. J. Pharm. Sci. & Res., 10(11), 2709-2714.
  • Leontiev, D. A., Gryzodub, O. I., Ivanov, L. V., Bevz, O. V., Vashchenko, O. V., & Volovyk N. V. (2018). The use of a mathematical model to describe thermograms to determine the drying end time: prospects for use in reference standards certification. Farmacom, 4, 25-32.
  • Leontiev, D. A., Petrus, V. V., Gryzodub, O. I., & Volovyk, N. V. (2018). Assay and uniformity of dosage units: non-uniformity effects and quality assurance. Farmacom, 2, 45-55.
  • Leontiev, D., Bevz, O., Volovyk, N., Gella, I., & Georgiyants, V. (2018). The synthesis and study of profiles of the ornidazole impurities. ScienceRise: Pharmaceutical Science1 (11), 4-11. doi:http://dx.doi.org/10.15587/2519-4852.2018.123387
  • Volovyk, N., Leontiev, D., & Denisenko, N. (2016). Methodological approach to the certification of reference standards of the State Pharmacopoeia of Ukraine. Arh. farm., 66, 301-302.
  • Leontiev, D., & Volovyk, N. (2016). Specificity of application of the uncertainty concept to the decision on compliance of medicines. Arh. farm., 66, 207-208.
  • Кotova, E.E., & Kotov, A.G. (2016). Pharmacopoeial reference standards as part of the herbal drug standardization in Ukraine. Farmacom, 2, 15-20.
  • Leontiev, D. A., Volovyk, N. V., Bevz, O. V., Vashchenko, O. V., & Budianska L. V. (2016). Study of the thermogravimetric analysis application to determine volatile impurities for the reference standards certification. ScienceRise: Pharmaceutical Science2 (2), 10-15. doi:http://dx.doi.org/10.15587/2519-4852.2016.74460
  • Leontiev, D. A., Podpruzhnikov, Y. V., & Volovyk, N. V. (2016). THE ROLE OF REFERENCE STANDARDS IN QUALITY ASSURANCE FOR MEDICINES: REGULATORY AND METROLOGICAL ASPECTS. Drug development & registration, 3, 180-188.
  • Leontiev, D. A., Volovyk, N. V., & Gryzodub, O. I. (2015). The system of pharmacopeial reference standards of the State Pharmacopoeia of Ukraine: the development concept and the current state. (2015). Pharm. Journal, 2, 29-37.
  • Kotov, A. G., Kotova, E. E., Leontiev, D. A., Gryzodub, O. I. (2014). Approaches to the establishment of herbal extracts as reference standards of the State Pharmacopoeia of Ukraine for identification by thin-layer chromatography. Farmacom, 3, 5-14.