Registration Number
0221U103692,
0118U003700
, R & D reports
Title
The development methodology of choice of generic medicines for the population with quality drugs Ukraine.
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Head
Ostаninа Nаtаlia V.,
Registration Date
24-02-2021
Organization
State Institution "OM Marzeev Institute of Public Health of the National Academy of Medical Sciences of Ukraine"
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OBJECT OF RESEARCH - normative documents related to the circulation of medicines, research methods of original and generic drugs, different groups of medicines. PURPOSE OF THE WORK - development of new methodological approaches to the choice of generic drugs to provide the population of Ukraine with quality and affordable drugs. RESEARCH METHODS - bibliographic, sociological, analytical, physicochemical and statistical. RESULTS OF WORK. The results of scientific research on the equivalence of original and generic drugs both in Ukraine and abroad are analyzed. It is proved that in Ukraine there is no database, which would be separated by completely different in the degree of evidence of efficacy and safety types of drugs. The factors leading to differences in the homogeneity of the mass of doses and the homogeneity of the dosage of the active substance of the studied drugs are determined. A technique has been developed (which investigated Nasonex analogues) that allows you to quickly and with low material costs to analyze the entire sequence of guaranteed doses for nasal sprays with the active pharmaceutical ingredient mometasone furoate. It is proposed to classify generics of oral drugs that contain active pharmaceutical ingredients in the form of solid phase (tablets, capsules, suspensions, powders) by potential hazard (namely lack of bioequivalence or possible side effects), as well as according to the class of Biopharmaceutical Classification. The paper analyzes the results of scientific research on the equivalence of original and generic medicines (drugs) both in Ukraine and abroad.
Product Description
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Brytsun Vasyl M
Humeniuk Oleksii A
Levin Mykhailo H
Meleshko Ruslan A
Tereshchenko Oksana M
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2021-02-24
