О. Popov, І.V. Kravchenko, V.Ye. Dоbrоvа, K. Tkachenko
{"title":"The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union","authors":"О. Popov, І.V. Kravchenko, V.Ye. Dоbrоvа, K. Tkachenko","doi":"10.24959/cphj.21.1548","DOIUrl":"https://doi.org/10.24959/cphj.21.1548","url":null,"abstract":"Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs.\u0000Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results.\u0000Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted.\u0000Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers.\u0000Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"102 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78309310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Subunit compositions of GABAA receptors determining the diversity of physiological processes and neurotropic properties of medicines","authors":"M. Golovenko","doi":"10.24959/cphj.21.1541","DOIUrl":"https://doi.org/10.24959/cphj.21.1541","url":null,"abstract":"Gamma-aminobutyric acid (GABA) became known as a potentially important chemical in the brain 50 years ago, but its significance as a neurotransmitter was fully found 16 years later. It is now known that at least 40 % of the inhibitory synaptic activity in the mammalian brain is accounted for by GABA. \u0000Аim. To analyze achievements in the study of the physiological and pharmacological role of GABA receptor subtypes, their potential applications in drug development and updated information on the clinical development of subtype-selective GABA receptor compounds. \u0000Results. The GABAA-receptor complex (GABA-RC) is ligand-gated ion channels with chloride conductance. These receptors contain α, β, and γ subunits, but δ, ε, θ, and ρ can be also present. The GABA binding site is located at the interface between α and β subunits where a number of important amino acids are also found. GABA-RC is sensitive to a wide range of drugs, e.g. benzodiazepines (BDZ), which are often used for their sedative/hypnotic and anxiolytic effects. Classical BDZ interact non-selectively with α1,3,5 βγ2 GABA-RС in the binding site located at the α+γ− interface. \u0000Conclusions. In addition to the potent and rapid pharmacotherapeutic action BDZ also possess some addictive potential (drug dependence), which appears after the interaction of molecules with α1-receptors. Using the selective targeting to separate subgroups not only the main effect of BDZ without side effects can be provided, but also one can use this approach in creating new analgesic medicines; we have demonstrated it on the example of propoxazepam (full agonist GABA-R).","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"97 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83914697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
V. A. Moroz, R. Al-Hadrawi, O. Andrieieva, Y. Timchenko, A. M. Semenov
{"title":"Ways of medicinal prevention and treatment of doxorubicin-induced cardiomyopathy in oncological patients","authors":"V. A. Moroz, R. Al-Hadrawi, O. Andrieieva, Y. Timchenko, A. M. Semenov","doi":"10.24959/CPHJ.21.1547","DOIUrl":"https://doi.org/10.24959/CPHJ.21.1547","url":null,"abstract":"The high incidence of malignant tumors is currently supported by the general ageing of the world population and unfavorable environmental factors. In 2018, 18.1 million new cases of cancer and 9.6 million deaths from them were registered in the world. At the same time, a significant increase in the life expectancy of these patients after the treatment noted over the past 20 years highlights the problem of side effects of the anticancer therapy. One of the most serious side effects is the development of doxorubicin-induced cardiomyopathy (DRIC). In all three distinct clinical forms (acute, early and late) DRIC can develop in 58 % of patients after using anticancer treatment regimens with the inclusion of doxorubicin. The review provides a detailed analysis of medicinal treatment regimens and preparations (ACE inhibitors, beta-blockers, statins, etc.) currently used, and evaluates their effectiveness and expected results. Currently, several therapeutic strategies have been proposed for the prevention and treatment of DRIC, each of them has certain positive results. At the same time, some therapeutic methods used in the clinic have some disadvantages.\u0000Conclusions. The limitations of the results of DRIC prevention achieved by the existing therapeutic regimens, as well as the possibilities for their prediction, have been stated. The need for further research to improve the effectiveness of medicinal prevention and treatment of DRIC is emphasized.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"112 1","pages":"4-12"},"PeriodicalIF":0.0,"publicationDate":"2021-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89787565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
O. Devinyak, E. M. Vashkeba-Bitler, M. Fizer, I. Stan, Yaroslava Deyak, O. Lytvyn
{"title":"The assortment analysis of chlorhexidine-containing medicines and procurement data of state and municipal organizations","authors":"O. Devinyak, E. M. Vashkeba-Bitler, M. Fizer, I. Stan, Yaroslava Deyak, O. Lytvyn","doi":"10.24959/cphj.21.1543","DOIUrl":"https://doi.org/10.24959/cphj.21.1543","url":null,"abstract":"Chlorhexidine is an effective cationic antiseptic and disinfectant that has been used in medical practice for decades. It is generally recommended to use different concentrations of aqueous or alcoholic solutions of chlorhexidine for different therapeutic purposes. \u0000Objective. To determine the proportions of different chlorhexidine concentrations in medicines purchased by state and municipal organizations and to identify possible issue of chlorhexidine formulations utilization in the suboptimal or insufficient concentrations. \u0000Results. The vast majority of the chlorhexidine-containing medicines found in the State Register of Medicines of Ukraine are 0.05% solutions for external use, 0.05% gels for dental and urological use and vaginal suppositories (pessaries) with 16 mg of chlorhexidine in one dose. While the most common representatives of chlorhexidine-containing medicines abroad are solutions with a concentration of 4% and 2%, as well as mouthwashes with a concentration of 0.12%. The highest share - 96% - among the procurements of chlorhexidine-containing medicines by state and municipal organizations is 0.05% aqueous solution for external use. Instructions for medical use of 0.05% aqueous chlorhexidine solution for external use contain indications that are not supported by international documents: WHO Model List of Essential Medicines and British National Formulary. \u0000Conclusions. The obtained results suggest probable cases of irrational use of chlorhexidine medicines in medical practice in Ukraine. The consequences of such cases are not limited to the failure to achieve therapeutic goals or to the development of nosocomial infection, but includes also the selection of chlorhexidine-resistant strains of microorganisms. \u0000Key words: chlorhexidine; assortment analysis; medicinal procurements study; suboptimal concentration; rational pharmacotherapy","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74326782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Laboratory toxicological diagnosis of trazodone intoxications","authors":"S. A. Karpushyna, S. V. Baiurka, S. Merzlikin","doi":"10.24959/cphj.21.1544","DOIUrl":"https://doi.org/10.24959/cphj.21.1544","url":null,"abstract":"When determining the cause of poisoning by antidepressant drugs, the data of laboratory toxicological studies of biofluids for the presence of this group of drugs are of key importance.\u0000Aim. To develop the methods for determining the antidepressant drug trazodone in the blood and urine samples using high-performance liquid chromatography with a UV spectrophotometric detection, which is suitable for analytical diagnosis of the thymoleptics intoxications.\u0000Materials and methods. The model samples of human biofluids spiked with trazodone were studied. The antidepressant was isolated from the blood and urine by the liquid-liquid extraction with methylene chloride from the alkaline medium at pH 9. Concomitant endogenous impurities were removed by extraction with diethyl ether from the acidic medium at pH 1. In the study of the blood the erythrocyte mass was pre-precipitated with the help of 10 % of trichloroacetic acid solution. Chromatographic analysis was performed on a microcolumn chromatograph using a column with a reversed-phase of C18.\u0000Results. The absolute retention time of trazodone in extracts from the model samples of biofluids was 17.91±0.09 min. The quantitative content of trazodone was determined at 250 nm by the calibration dependence of the chromatographic peak area on the concentration (μg/ml) y=(1.74∙10-3±1∙10-5)x. Under the indicated extraction conditions, 35±4 % and 78±4 % of trazodone were isolated from the blood and urine, respectively.\u0000Conclusions. The methods of trazodone isolation from the biofliuds by liquid extraction followed by the determination of the drug by high performance liquid chromatography with a multiwave UV spectrophotometric detection have been developed. The methods are recommended for using in the practice of forensic and clinical toxicology.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"38-40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78293422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Asthma in children.","authors":"P. A. Simon, C. M. Murphy, S. L. Coonce","doi":"10.33140/jpnb.06.01.01","DOIUrl":"https://doi.org/10.33140/jpnb.06.01.01","url":null,"abstract":"Asthma is one of the most common chronic diseases of the airways, characterized by allergic inflammation in the airways, often as a result of exposure to allergens, cold air, tobacco smoke, exercise, or emotional stress. The most common asthma symptoms in children are: cough, shortness of breath with wheezing, chest pressure and shortness of breath. Asthma is an incurable disease, but its symptoms, which range from mild to life-threatening, can be controlled with medication and lifestyle, thus ensuring a full and normal life for the child.","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"28 1","pages":"386-7"},"PeriodicalIF":0.0,"publicationDate":"2021-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85915710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
O. Mishchenko, K. Kalko, V. F. Оstashko, Yu. I. Greshko, P. Klepach, Y. Honcharuk
{"title":"Clinical and economic aspects of fibrates","authors":"O. Mishchenko, K. Kalko, V. F. Оstashko, Yu. I. Greshko, P. Klepach, Y. Honcharuk","doi":"10.24959/cphj.20.1536","DOIUrl":"https://doi.org/10.24959/cphj.20.1536","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"113 1","pages":"15-22"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75032370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
T. Sakharova, N. Bezugla, I. Otrishko, K. Zupanets, K. Ratushna
{"title":"Pharmaceutical care in the treatment of acute respiratory viral infections: the phytoneering possibilities from the perspective of evidence-based medicine","authors":"T. Sakharova, N. Bezugla, I. Otrishko, K. Zupanets, K. Ratushna","doi":"10.24959/cphj.20.1530","DOIUrl":"https://doi.org/10.24959/cphj.20.1530","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"58 1","pages":"4-14"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87441291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of the effect of the combination of glucosamine derivatives with quercetin on the morphofunctional state of the thymus and spleen of rats under the toxic effect of doxorubicin","authors":"K. V. Vietrova, T. Sakharova","doi":"10.24959/cphj.20.1540","DOIUrl":"https://doi.org/10.24959/cphj.20.1540","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"57 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87075816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The assessment of the oral cavity biocenosis state in patients with type II diabetes mellitus when using removable dentures","authors":"R. Badalov, G. Kovalenko","doi":"10.24959/cphj.20.1539","DOIUrl":"https://doi.org/10.24959/cphj.20.1539","url":null,"abstract":"","PeriodicalId":10498,"journal":{"name":"Clinical pharmacy","volume":"37 1","pages":"30-36"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84768571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}