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  • Publications
  • Research data
  • Other research products
  • 2018-2022
  • Open Access
  • 03 medical and health sciences
  • 030212 general & internal medicine
  • Ведомости Научного центра экспертизы средств медицинского применения

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  • Open Access
    Authors: 
    G. I. Gorodetskaya; V. V. Arkhipov; E. S. Melnikov; T. A. Rodina;
    Publisher: SCEEMP

    Rational use of glybenclamide products in the treatment of patients with type 2 diabetes remains a high-priority task. The paper offers a summary of the main groups of glibenclamide drugs and describes pharmacogenetics of glybenclamide. Glibenclamide is metabolized by the enzyme cytochrome P450 2C9 (CYP2C9). Individuals with genetically determined low CYP2C9 activity are at an increased risk of hypoglycaemia. Carriers of CYP2C9*3 and CYP2C9*2 alleles tend to have higher concentrations of glybenclamide in blood and increased insulin secretion. Pharmacogenetic testing of patients and drug concentration monitoring using HPLC-MS can help reduce the risk of hypoglycemia during glibenclamide treatment. Based on literature review the authors selected the method characterised by a simple sample preparation procedure, short analysis time, and a wide analytical range for the substances being determined. This method can be useful both for bioequivalence studies and evaluation of glibenclamide products interchangeability. Glibenclamide pharmacokinetics is characterised by high interindividual variability. This may lead to both an increased risk of hypoglycemia and drug inefficacy, therefore, when prescribing glibenclamide, a physician should carefully control the efficacy and safety of drug therapy.

  • Open Access
    Authors: 
    N. P. Neugodova; O. V. Shapovalova; G. A. Sapozhnikova; E. O. Stepanyuk;
    Publisher: SCEEMP

    The State Pharmacopoeia of the Russian Federation, 14th edition states that implants are a sterile dosage form, and have to be tested for pyrogens. However, it does not provide details on how the test should be performed for this dosage form.The aim of the study was to develop a LAL test procedure for detection of bacterial endotoxins (BE) in implants, using the example of a goserelin product.Materials and methods: BE extraction from the implant surface into an aqueous medium was performed with subsequent BE detection in the extract by turbidimetric kinetic test. The implant was then dissolved in dimethyl sulfoxide, and the obtained goserelin solution was tested for BEs using the gel-clot test.Results: the analysis of the Russian and foreign pharmacopoeial approaches to pyrogenic substance detection in hormonal implants helped to develop two sample preparation procedures for determination of BE content (in the extract and the implant solution). It was demonstrated that the BE content in the water extract did not exceed 0.01 EU/mL and was less than 0.07 EU per implant. The BE content in the implant solution was less than 8.3 EU per 1 mg of goserelin, which is almost eleven-fold lower than the theoretically-derived limit.Conclusions: the authors developed two test procedures for BE detection in hormonal implants using the LAL test, which could be included in manufacturers’ product files. The first procedure involves testing of the water extract from the implant surface and establishes the BE limit of no more than 20 EU/product. The second procedure involves complete dissolution of the implant in dimethyl sulfoxide and establishes the limit of not more than 97.22 EU per 1 mg of goserelin.

  • Open Access
    Authors: 
    O, A. Bezborodova; A. A. Pankratov; E. R. Nemtsova; Yu. B. Venediktova; M. S. Vorontsova; G. N. Engalycheva; R. D. Syubaev;
    Publisher: SCEEMP

    The decoding of the DNA structure and development of new molecular methods of its analysis, as well as identification of specific genomic changes responsible for malignant transformation, have become the turning points in elaboration of novel anti-tumour drugs directed against molecular and genetic targets of tumor growth. Transition from empirical screening of agents inhibiting tumour cell proliferation to molecule-targeted analytical methods has raised a number of serious methodological issues regarding preclinical evaluation of novel medicines. The objective of this paper was to analyse general principles and features of preclinical efficacy and safety studies of different classes of modern anti-tumour drugs with a view to improve existing national guidelines. The paper reviews various aspects of preclinical studies of different classes of anti-tumour drugs (small molecule chemotherapy drugs, hormones and hormone antagonists, alkylating agents and antimetabolites, microbial and herbal medicines, as well as monoclonal antibodies). The article explores general principles of studying the drugs’ pharmacological activity in vitro, ex vivo, and in vivo, and evaluating their pharmacokinetic parameters. It describes various methods and models of research, summarises specific aspects of determination of genotoxicity, carcinogenicity, reproductive toxicity, mutagenicity, acute and chronic toxicity of various groups of medicines. It also lists criteria for selecting drug doses for toxicokinetic studies. The need for harmonisation of national requirements for conducting preclinical studies with the European standards entails alignment of terminology and further development of general algorithms for selecting doses and determining the necessary scope of research. The use of biomarkers in preclinical studies will make it possible to exclude inefficient compounds from further research.

  • Open Access
    Authors: 
    V. V. Arkhipov; E. A. Sokova; G. I. Gorodetskaya; O. A. Demidova; T. V. Aleksandrova;
    Publisher: SCEEMP

    This article looks into interchangeability and therapeutic equivalence of innovator and generic anticonvulsants — the first-generation and new antiepileptic drugs (AEDs). The results of a number of clinical trials assessing therapeutic equivalence of generic AEDs support the opinion that these medicines could only be substituted provided an ultra-cautious approach is used, even if the case involves only one International Nonproprietary Name, including, but not limited to different dosage forms of one and the same product. The aim of the study was to analyse factors leading to incorrect assessment of therapeutic equivalence of new and generic anticonvulsant drugs, and to improve methodological approaches to conducting clinical trials of these products. The paper cites data from Russian and foreign sources which state that the substitution of AEDs in some patients in full remission may result in adverse reactions or relapse of seizures. The analysis of the experience of scientific, expert, and regulatory institutions made it possible to develop a course of actions to be used when substituting AEDs and conducting clinical trials that assess therapeutic equivalence of new and generic anticonvulsants. The proposed methodology will help minimise potential health risks brought about by various factors that result in incorrect assessment of AEDs therapeutic equivalence and interchangeability.

  • Open Access Russian
    Authors: 
    E. V. Shekunova; M. A. Kovaleva; M. N. Makarova; V. G. Makarov;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    One of the major obstacles to effective translational medicine is the challenge of translating animal research results into clinical studies. Scientific literature mainly addresses the selection of the drug dose at initiation of clinical trials (Phase 1). Appropriate selection of doses is also essential for preclinical toxicology and pharmacology studies. Some basic principles that are used when translating dosages from animal models to humans are applicable to selection and justification of doses when planning and conducting preclinical studies. The paper provides an overview of the main methods that can be used for selection and justification of animal doses in preclinical studies, e.g. cross-species dose conversion using body surface area scaling. It summarises situations when doses may be directly converted based on body weight. The paper gives special attention to cross-species dose translation according to pharmacokinetic data. There is no one-size-fits-all approach to cross-species translation; dose conversion must be scientifically justified taking into consideration all information available on the test drug, i.e. its chemical structure, intended route of administration, pharmacokinetic parameters, preclinical and clinical data on pharmacodynamics, and inter-species differences in pharmacokinetics and pharmacodynamics.

  • Open Access
    Authors: 
    G. E. Kodina; A. O. Malysheva;
    Publisher: SCEEMP

    One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market.

  • Open Access Russian
    Authors: 
    N. V. Eremina; L. G. Kolik; R. U. Ostrovskaya; A. D. Durnev;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Neurotoxic effects are one of the common reasons for discontinuation of preclinical and/or clinical studies. Preclinical evaluation of neurotoxic effects is complicated due to a wide range of manifestations and degrees of severity. Current experimental approaches to neurotoxicity assessment are cumbersome, laborious and not adapted enough for preclinical studies in the early stages of drug development. The aim of the study was to review existing approaches to experimental assessment of neurotoxic potential of new drugs and to discuss the need for and feasibility of developing and using integrated rapid neurotoxicity tests for early assessment of a pharmacological project’s potential. The authors reviewed scientific literature and guidance documents and analysed current approaches to chemical compound neurotoxicity assessment in laboratory animals. The paper analyses the main issues of neurotoxicity assessment for new drugs and compares Irwin tests with the functional observation battery. It analyses issues related to assessment of drugs’ effects on the development and maturation of central nervous system functions at pre- and postnatal stages. It was determined that the current practice is not sufficient for assessment of potential adverse effects on cognitive functions. The authors assessed factors affecting cognitive functions of rodents during studies. The “Acute suppression of the exploratory and orientation response” and “Extrapolation escape task” tests were proposed for validation as potential rapid tests for detection of an array of organic and functional neurotoxic disorders at early stages of preclinical studies.

  • Open Access
    Authors: 
    N. S. Tereshina; M. N. Lyakina; O. A. Naumova;
    Publisher: SCEEMP

    Sea water and sea salt obtained from it are widely used as substances in the production of medicinal products. Complex chemical composition of sea water which contains various salts, calls for the development of a common quality standard for sea water-based medicines. The aim of the study was to analyse and summarise available data on the sources of sea water-based medicines, and on the current test methods, as well as to develop a unified approach to quality control. The paper summarises information on the use of sea water for medical purposes. It presents comparative data on the chemical composition of sea water obtained from different sources, manufacturing technologies of sea water-based medicines, and composition of medicines produced from sea water or sea salt. The paper summarises data on the use of sea water for the production of various dosage forms: drops, sprays, aerosols. The study revealed qualitative and quantitative differences in the content of major cations and anions in drug products. The authors analysed the use of various chemical and physico-chemical test methods for qualitative and quantitative characterisation of medicines. It was concluded that there is a need to harmonise quality control methods for sea water-based medicines.

  • Open Access
    Authors: 
    O. A. Goroshko; L. M. Krasnykh; V. G. Kukes; V. I. Zozina;
    Publisher: SCEEMP

    The article examines the role of ubiquinone as a redox molecule whose functions consist in electron transport in the mitochondrial respiratory chain and regeneration of endogenous antioxidants. Changes in electron redox pathways cause uncontrolled release of reactive oxygen species, which leads to oxidative stress and development of pathologies. The objective of the study was to determine the content of coenzyme Q10 and its redox status in the human body as a biomarker of oxidative stress in various pathologies. This was achieved by assessing and consolidating data on changes in concentrations of the oxidized, reduced ubiquinone forms and total ubiquinone in various pathologies. Total serum ubiquinone was reduced in patients with chronic heart failure (0.68 μmol/L) compared with the control group (0.97 μmol/L). The redox status, expressed as the [ubiquinol]/ [ubiquinone] concentration ratio, decreased in patients with coronary heart disease (0.49 ± 0.34), diabetes (0.26 ± 0.16) compared with the healthy subjects (1.23–1.41). A negative correlation with malonic dialdehyde was observed. The authors analysed the possibility of assessing the efficacy of statin therapy by plasma ubiquinone concentration in patients. Patients with hyperlipidemia who received statins showed a statistically significant reduction in ubiquinol concentration after taking the drug (from 0.81 to 0.46 μg/mL) and the [ubiquinone]/[total ubiquinone] ratio (from 11 to 10 %), which confirms the potential mechanism of statinassociated muscle injury development. Thus, coenzyme Q10 redox status, as well as the concentrations of oxidized, reduced and total ubiquinone can be effective biomarkers of oxidative stress in cardiovascular diseases, diabetes, as well as an important indicator in evaluating the efficacy of hyperlipidemia treatment.

  • Open Access
    Authors: 
    I. A. Proskurina; E. A. Petraneva; D. V. Goryachev;
    Publisher: SCEEMP

    Diabetes is a serious public health problem and one of the major chronic noncommunicable diseases. A lengthy stepwise treatment, and the need for an individualised approach to antidiabetic therapy, pose serious challenges for medicine developers. For all new hypoglycaemic medicines, there has been a centralised authorisation procedure in the European Union (EU) since 2005, which ensures a unified approach to efficacy and safety assessment. The aim of the study was to analyse current requirements for planning clinical trials of hypoglycaemic medicines containing new active substances (except for insulin products). The recommendations for diagnosis and treatment of type 2 diabetes, prepared by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) in 2019, suggest a step-by-step approach to intensification of treatment to maintain glycaemic targets, which takes account of concomitant cardiovascular or other diseases, and clinical characteristics of patients. The analysis of EASD/ADA documents and scientific literature helped to develop recommendations on the basic principles of planning and conducting clinical trials at the final stages of hypoglycaemic medicine development. The paper describes new approaches to clinical trials, which allow for a more reliable assessment of the treatment effectiveness. The strategy for the assessment of therapeutic effect should be carefully planned, justified, and reflected in variables of interest, clinical trial design, and statistical analysis of the trial results. The main efficacy criterion in confirmatory clinical trials of hypoglycaemic medicines should be the demonstration of benefits in improving glycaemic control. The medicine’s effect on the body weight may be considered as a secondary endpoint. An essential requirement is confirmation of the medicines’ cardiovascular safety, while potential additional benefits are reduction or prevention of risks of cardiovascular disease development. The clinical trial protocol should provide definitions for intercurrent events and hypoglycaemia. A comprehensive safety study of a new hypoglycaemic medicine should involve identification of anticipated or known side effects characteristic of a particular pharmacological class. The provided recommendations may be helpful for medicine developers, and for experts who perform assessment of clinical trial programmes and regulatory submissions for hypoglycaemic medicines.

Advanced search in
Research products
arrow_drop_down
Searching FieldsTerms
Any field
arrow_drop_down
includes
arrow_drop_down
Include:
24 Research products, page 1 of 3
  • Open Access
    Authors: 
    G. I. Gorodetskaya; V. V. Arkhipov; E. S. Melnikov; T. A. Rodina;
    Publisher: SCEEMP

    Rational use of glybenclamide products in the treatment of patients with type 2 diabetes remains a high-priority task. The paper offers a summary of the main groups of glibenclamide drugs and describes pharmacogenetics of glybenclamide. Glibenclamide is metabolized by the enzyme cytochrome P450 2C9 (CYP2C9). Individuals with genetically determined low CYP2C9 activity are at an increased risk of hypoglycaemia. Carriers of CYP2C9*3 and CYP2C9*2 alleles tend to have higher concentrations of glybenclamide in blood and increased insulin secretion. Pharmacogenetic testing of patients and drug concentration monitoring using HPLC-MS can help reduce the risk of hypoglycemia during glibenclamide treatment. Based on literature review the authors selected the method characterised by a simple sample preparation procedure, short analysis time, and a wide analytical range for the substances being determined. This method can be useful both for bioequivalence studies and evaluation of glibenclamide products interchangeability. Glibenclamide pharmacokinetics is characterised by high interindividual variability. This may lead to both an increased risk of hypoglycemia and drug inefficacy, therefore, when prescribing glibenclamide, a physician should carefully control the efficacy and safety of drug therapy.

  • Open Access
    Authors: 
    N. P. Neugodova; O. V. Shapovalova; G. A. Sapozhnikova; E. O. Stepanyuk;
    Publisher: SCEEMP

    The State Pharmacopoeia of the Russian Federation, 14th edition states that implants are a sterile dosage form, and have to be tested for pyrogens. However, it does not provide details on how the test should be performed for this dosage form.The aim of the study was to develop a LAL test procedure for detection of bacterial endotoxins (BE) in implants, using the example of a goserelin product.Materials and methods: BE extraction from the implant surface into an aqueous medium was performed with subsequent BE detection in the extract by turbidimetric kinetic test. The implant was then dissolved in dimethyl sulfoxide, and the obtained goserelin solution was tested for BEs using the gel-clot test.Results: the analysis of the Russian and foreign pharmacopoeial approaches to pyrogenic substance detection in hormonal implants helped to develop two sample preparation procedures for determination of BE content (in the extract and the implant solution). It was demonstrated that the BE content in the water extract did not exceed 0.01 EU/mL and was less than 0.07 EU per implant. The BE content in the implant solution was less than 8.3 EU per 1 mg of goserelin, which is almost eleven-fold lower than the theoretically-derived limit.Conclusions: the authors developed two test procedures for BE detection in hormonal implants using the LAL test, which could be included in manufacturers’ product files. The first procedure involves testing of the water extract from the implant surface and establishes the BE limit of no more than 20 EU/product. The second procedure involves complete dissolution of the implant in dimethyl sulfoxide and establishes the limit of not more than 97.22 EU per 1 mg of goserelin.

  • Open Access
    Authors: 
    O, A. Bezborodova; A. A. Pankratov; E. R. Nemtsova; Yu. B. Venediktova; M. S. Vorontsova; G. N. Engalycheva; R. D. Syubaev;
    Publisher: SCEEMP

    The decoding of the DNA structure and development of new molecular methods of its analysis, as well as identification of specific genomic changes responsible for malignant transformation, have become the turning points in elaboration of novel anti-tumour drugs directed against molecular and genetic targets of tumor growth. Transition from empirical screening of agents inhibiting tumour cell proliferation to molecule-targeted analytical methods has raised a number of serious methodological issues regarding preclinical evaluation of novel medicines. The objective of this paper was to analyse general principles and features of preclinical efficacy and safety studies of different classes of modern anti-tumour drugs with a view to improve existing national guidelines. The paper reviews various aspects of preclinical studies of different classes of anti-tumour drugs (small molecule chemotherapy drugs, hormones and hormone antagonists, alkylating agents and antimetabolites, microbial and herbal medicines, as well as monoclonal antibodies). The article explores general principles of studying the drugs’ pharmacological activity in vitro, ex vivo, and in vivo, and evaluating their pharmacokinetic parameters. It describes various methods and models of research, summarises specific aspects of determination of genotoxicity, carcinogenicity, reproductive toxicity, mutagenicity, acute and chronic toxicity of various groups of medicines. It also lists criteria for selecting drug doses for toxicokinetic studies. The need for harmonisation of national requirements for conducting preclinical studies with the European standards entails alignment of terminology and further development of general algorithms for selecting doses and determining the necessary scope of research. The use of biomarkers in preclinical studies will make it possible to exclude inefficient compounds from further research.

  • Open Access
    Authors: 
    V. V. Arkhipov; E. A. Sokova; G. I. Gorodetskaya; O. A. Demidova; T. V. Aleksandrova;
    Publisher: SCEEMP

    This article looks into interchangeability and therapeutic equivalence of innovator and generic anticonvulsants — the first-generation and new antiepileptic drugs (AEDs). The results of a number of clinical trials assessing therapeutic equivalence of generic AEDs support the opinion that these medicines could only be substituted provided an ultra-cautious approach is used, even if the case involves only one International Nonproprietary Name, including, but not limited to different dosage forms of one and the same product. The aim of the study was to analyse factors leading to incorrect assessment of therapeutic equivalence of new and generic anticonvulsant drugs, and to improve methodological approaches to conducting clinical trials of these products. The paper cites data from Russian and foreign sources which state that the substitution of AEDs in some patients in full remission may result in adverse reactions or relapse of seizures. The analysis of the experience of scientific, expert, and regulatory institutions made it possible to develop a course of actions to be used when substituting AEDs and conducting clinical trials that assess therapeutic equivalence of new and generic anticonvulsants. The proposed methodology will help minimise potential health risks brought about by various factors that result in incorrect assessment of AEDs therapeutic equivalence and interchangeability.

  • Open Access Russian
    Authors: 
    E. V. Shekunova; M. A. Kovaleva; M. N. Makarova; V. G. Makarov;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    One of the major obstacles to effective translational medicine is the challenge of translating animal research results into clinical studies. Scientific literature mainly addresses the selection of the drug dose at initiation of clinical trials (Phase 1). Appropriate selection of doses is also essential for preclinical toxicology and pharmacology studies. Some basic principles that are used when translating dosages from animal models to humans are applicable to selection and justification of doses when planning and conducting preclinical studies. The paper provides an overview of the main methods that can be used for selection and justification of animal doses in preclinical studies, e.g. cross-species dose conversion using body surface area scaling. It summarises situations when doses may be directly converted based on body weight. The paper gives special attention to cross-species dose translation according to pharmacokinetic data. There is no one-size-fits-all approach to cross-species translation; dose conversion must be scientifically justified taking into consideration all information available on the test drug, i.e. its chemical structure, intended route of administration, pharmacokinetic parameters, preclinical and clinical data on pharmacodynamics, and inter-species differences in pharmacokinetics and pharmacodynamics.

  • Open Access
    Authors: 
    G. E. Kodina; A. O. Malysheva;
    Publisher: SCEEMP

    One of the prerequisites for successful application of nuclear medicine technologies is the production and clinical use of radiopharmaceuticals (RPs) of a reliably high quality. The aim of the review is to discuss specific properties of RPs, which stipulate specific approaches to their production (or preparation) and quality control. The decisive requirement for the management of RPs at all stages of their life cycle is the observance of the radiation safety rules and regulations. The paper considers the main approaches to assessing the risks of medical radiation exposure to patients and radiation protection of nuclear medicine staff. The choice of a particular quality parameter and the corresponding analytical procedure should be made taking into account the duration of the test, which, like the production time, should be comparable with the radionuclide half-life. The feasibility of the analytical procedure should also be taken into account, given the high radioactivity of the samples tested. Now that theranostics has caught on, new approaches are being developed all over the world concerning regulatory aspects of transition from preclinical studies of RPs to clinical trials, because, according to experts, this is becoming a key condition for rapid implementation of nuclear medicine achievements. The results and conclusions of the present study can be used in the development and expert review of monographs and other specifications required for RP marketing and use. The results of the analysis suggest that it is necessary to develop specific requirements and guidelines for RP testing and evaluation for their successful promotion on the EAEU market.

  • Open Access Russian
    Authors: 
    N. V. Eremina; L. G. Kolik; R. U. Ostrovskaya; A. D. Durnev;
    Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”

    Neurotoxic effects are one of the common reasons for discontinuation of preclinical and/or clinical studies. Preclinical evaluation of neurotoxic effects is complicated due to a wide range of manifestations and degrees of severity. Current experimental approaches to neurotoxicity assessment are cumbersome, laborious and not adapted enough for preclinical studies in the early stages of drug development. The aim of the study was to review existing approaches to experimental assessment of neurotoxic potential of new drugs and to discuss the need for and feasibility of developing and using integrated rapid neurotoxicity tests for early assessment of a pharmacological project’s potential. The authors reviewed scientific literature and guidance documents and analysed current approaches to chemical compound neurotoxicity assessment in laboratory animals. The paper analyses the main issues of neurotoxicity assessment for new drugs and compares Irwin tests with the functional observation battery. It analyses issues related to assessment of drugs’ effects on the development and maturation of central nervous system functions at pre- and postnatal stages. It was determined that the current practice is not sufficient for assessment of potential adverse effects on cognitive functions. The authors assessed factors affecting cognitive functions of rodents during studies. The “Acute suppression of the exploratory and orientation response” and “Extrapolation escape task” tests were proposed for validation as potential rapid tests for detection of an array of organic and functional neurotoxic disorders at early stages of preclinical studies.

  • Open Access
    Authors: 
    N. S. Tereshina; M. N. Lyakina; O. A. Naumova;
    Publisher: SCEEMP

    Sea water and sea salt obtained from it are widely used as substances in the production of medicinal products. Complex chemical composition of sea water which contains various salts, calls for the development of a common quality standard for sea water-based medicines. The aim of the study was to analyse and summarise available data on the sources of sea water-based medicines, and on the current test methods, as well as to develop a unified approach to quality control. The paper summarises information on the use of sea water for medical purposes. It presents comparative data on the chemical composition of sea water obtained from different sources, manufacturing technologies of sea water-based medicines, and composition of medicines produced from sea water or sea salt. The paper summarises data on the use of sea water for the production of various dosage forms: drops, sprays, aerosols. The study revealed qualitative and quantitative differences in the content of major cations and anions in drug products. The authors analysed the use of various chemical and physico-chemical test methods for qualitative and quantitative characterisation of medicines. It was concluded that there is a need to harmonise quality control methods for sea water-based medicines.

  • Open Access
    Authors: 
    O. A. Goroshko; L. M. Krasnykh; V. G. Kukes; V. I. Zozina;
    Publisher: SCEEMP

    The article examines the role of ubiquinone as a redox molecule whose functions consist in electron transport in the mitochondrial respiratory chain and regeneration of endogenous antioxidants. Changes in electron redox pathways cause uncontrolled release of reactive oxygen species, which leads to oxidative stress and development of pathologies. The objective of the study was to determine the content of coenzyme Q10 and its redox status in the human body as a biomarker of oxidative stress in various pathologies. This was achieved by assessing and consolidating data on changes in concentrations of the oxidized, reduced ubiquinone forms and total ubiquinone in various pathologies. Total serum ubiquinone was reduced in patients with chronic heart failure (0.68 μmol/L) compared with the control group (0.97 μmol/L). The redox status, expressed as the [ubiquinol]/ [ubiquinone] concentration ratio, decreased in patients with coronary heart disease (0.49 ± 0.34), diabetes (0.26 ± 0.16) compared with the healthy subjects (1.23–1.41). A negative correlation with malonic dialdehyde was observed. The authors analysed the possibility of assessing the efficacy of statin therapy by plasma ubiquinone concentration in patients. Patients with hyperlipidemia who received statins showed a statistically significant reduction in ubiquinol concentration after taking the drug (from 0.81 to 0.46 μg/mL) and the [ubiquinone]/[total ubiquinone] ratio (from 11 to 10 %), which confirms the potential mechanism of statinassociated muscle injury development. Thus, coenzyme Q10 redox status, as well as the concentrations of oxidized, reduced and total ubiquinone can be effective biomarkers of oxidative stress in cardiovascular diseases, diabetes, as well as an important indicator in evaluating the efficacy of hyperlipidemia treatment.

  • Open Access
    Authors: 
    I. A. Proskurina; E. A. Petraneva; D. V. Goryachev;
    Publisher: SCEEMP

    Diabetes is a serious public health problem and one of the major chronic noncommunicable diseases. A lengthy stepwise treatment, and the need for an individualised approach to antidiabetic therapy, pose serious challenges for medicine developers. For all new hypoglycaemic medicines, there has been a centralised authorisation procedure in the European Union (EU) since 2005, which ensures a unified approach to efficacy and safety assessment. The aim of the study was to analyse current requirements for planning clinical trials of hypoglycaemic medicines containing new active substances (except for insulin products). The recommendations for diagnosis and treatment of type 2 diabetes, prepared by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) in 2019, suggest a step-by-step approach to intensification of treatment to maintain glycaemic targets, which takes account of concomitant cardiovascular or other diseases, and clinical characteristics of patients. The analysis of EASD/ADA documents and scientific literature helped to develop recommendations on the basic principles of planning and conducting clinical trials at the final stages of hypoglycaemic medicine development. The paper describes new approaches to clinical trials, which allow for a more reliable assessment of the treatment effectiveness. The strategy for the assessment of therapeutic effect should be carefully planned, justified, and reflected in variables of interest, clinical trial design, and statistical analysis of the trial results. The main efficacy criterion in confirmatory clinical trials of hypoglycaemic medicines should be the demonstration of benefits in improving glycaemic control. The medicine’s effect on the body weight may be considered as a secondary endpoint. An essential requirement is confirmation of the medicines’ cardiovascular safety, while potential additional benefits are reduction or prevention of risks of cardiovascular disease development. The clinical trial protocol should provide definitions for intercurrent events and hypoglycaemia. A comprehensive safety study of a new hypoglycaemic medicine should involve identification of anticipated or known side effects characteristic of a particular pharmacological class. The provided recommendations may be helpful for medicine developers, and for experts who perform assessment of clinical trial programmes and regulatory submissions for hypoglycaemic medicines.

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