Pub Date : 2021-03-10DOI: 10.30895/1991-2919-2021-11-1-55-69
E. Petrova, D. Goryachev, A. D. Kuznetsova
. The need for development of a clinical trial guidance for medicines for bronchial asthma is brought about by the im- provement of requirements for research programmes for new medicines. The aim of the study was to develop a methodological approach to conducting clinical trials of bronchial asthma medicines in Russia in line with the existing international requirements. The authors analysed regulatory documentation on the development of medicines for treatment of bronchial asthma in adults tak-ing into account the current clinical guidelines, and specific aspects of developing medicines for treatment of bronchial asthma in children. The paper also analyses some clinical research aspects related to the development of immunotherapy. The analysis of up-to-date Russian and international clinical guidelines for bronchial asthma treatment, which are focused on bronchial asthma management using basic therapy, revealed the need to use revised disease concepts and new criteria to assess the efficacy of asthma medicines. The authors formulated consistent approaches to planning a clinical development programme for medicines for bron- chial asthma, and suggested methodology for conducting clinical research based on recommendations of the European Medicines Agency. астмы (Global Initiative for Asthma, GINA; Global Strategy for Asthma Management and Prevention).
{"title":"Planning a Clinical Development Programme for Medicines for Bronchial Asthma","authors":"E. Petrova, D. Goryachev, A. D. Kuznetsova","doi":"10.30895/1991-2919-2021-11-1-55-69","DOIUrl":"https://doi.org/10.30895/1991-2919-2021-11-1-55-69","url":null,"abstract":". The need for development of a clinical trial guidance for medicines for bronchial asthma is brought about by the im- provement of requirements for research programmes for new medicines. The aim of the study was to develop a methodological approach to conducting clinical trials of bronchial asthma medicines in Russia in line with the existing international requirements. The authors analysed regulatory documentation on the development of medicines for treatment of bronchial asthma in adults tak-ing into account the current clinical guidelines, and specific aspects of developing medicines for treatment of bronchial asthma in children. The paper also analyses some clinical research aspects related to the development of immunotherapy. The analysis of up-to-date Russian and international clinical guidelines for bronchial asthma treatment, which are focused on bronchial asthma management using basic therapy, revealed the need to use revised disease concepts and new criteria to assess the efficacy of asthma medicines. The authors formulated consistent approaches to planning a clinical development programme for medicines for bron- chial asthma, and suggested methodology for conducting clinical research based on recommendations of the European Medicines Agency. астмы (Global Initiative for Asthma, GINA; Global Strategy for Asthma Management and Prevention).","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81290921","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}
Pub Date : 2021-03-10DOI: 10.30895/1991-2919-2021-11-1-16-23
A. Beláňová, E. L. Kovaleva, L. I. Mit’kina
Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shelf life for the product. The aim of this study was to compare current requirements for stability testing of medicinal products in the Russian Federation and the Eurasian Economic Union (EAEU). The study covered stability testing of small-molecule medicines. The paper describes evolution of approaches to stability testing in the Russian Federation. It summarises the main differences in basic requirements for stability testing as stipulated in the State Pharmacopoeia of the Russian Federation (Ph. Rus.) XIII edition, Ph. Rus. XIV edition, and EAEU regulations. The study demonstrated that the Russian Federation lacks regulations containing specific requirements for stability testing performed to support variations to marketing authorisation documentation. The Ph. Rus. XIV edition does not specify the extent of stability testing to be performed after switching to another manufacturer of the active ingredient or introduction into operation of a new manufacturing site where the medicinal product will be produced. At the same time, the EAEU regulatory documents contain requirements for stability testing for each type of the most frequent variations to marketing authorisation documentation. The study demonstrated the continuing relevance of bringing the Russian regulations on stability testing in line with those of the EAEU.
{"title":"Comparison of Approaches to Stability Testing of Medicines in the Russian Federation and the Eurasian Economic Union","authors":"A. Beláňová, E. L. Kovaleva, L. I. Mit’kina","doi":"10.30895/1991-2919-2021-11-1-16-23","DOIUrl":"https://doi.org/10.30895/1991-2919-2021-11-1-16-23","url":null,"abstract":"Stability testing gives necessary data on the effect of such factors as temperature, light, humidity, etc. on the medicinal product quality. The results of these studies help to select suitable primary and secondary packaging and to determine storage conditions and shelf life for the product. The aim of this study was to compare current requirements for stability testing of medicinal products in the Russian Federation and the Eurasian Economic Union (EAEU). The study covered stability testing of small-molecule medicines. The paper describes evolution of approaches to stability testing in the Russian Federation. It summarises the main differences in basic requirements for stability testing as stipulated in the State Pharmacopoeia of the Russian Federation (Ph. Rus.) XIII edition, Ph. Rus. XIV edition, and EAEU regulations. The study demonstrated that the Russian Federation lacks regulations containing specific requirements for stability testing performed to support variations to marketing authorisation documentation. The Ph. Rus. XIV edition does not specify the extent of stability testing to be performed after switching to another manufacturer of the active ingredient or introduction into operation of a new manufacturing site where the medicinal product will be produced. At the same time, the EAEU regulatory documents contain requirements for stability testing for each type of the most frequent variations to marketing authorisation documentation. The study demonstrated the continuing relevance of bringing the Russian regulations on stability testing in line with those of the EAEU.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"60 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90631623","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}
Pub Date : 2021-03-10DOI: 10.30895/10.30895/1991-2919-2021-11-1-44-48
N. Antonova, I. M. Morgunov, S. S. Prokhvatilova, E. Shefer, O. Evdokimova, A. Beketova, M. N. Lyakina
Abstract. Identification of hellebore (Veratrum Lobelianum Bernh.) herbal substance, as well as hellebore-based herbal preparation and herbal medicinal product by the same group of biologically active substances using the same test method is in line with the so-called “consistent standardisation” principle.The aim of the study was to develop a harmonised approach to identification of steroidal alkaloids in hellebore products (hellebore water, hellebore tincture) and hellebore herbal substance (hellebore rhizomes with roots).Materials and methods: samples of hellebore water, hellebore tincture, and hellebore rhizomes with roots were analysed by high-performance thin-layer chromatography (HPTLC) using an HPTLC plate.Results: the authors developed a harmonised identification procedure for products made from hellebore rhizomes with roots (herbal substance, herbal preparation, and herbal medicinal product) based on HPTLC detection of steroidal alkaloids. The results of the study will be used to prepare amendments to the Identification part of monograph FS.2.5.0104.18 “Hellebore rhizomes with roots”. The developed test procedure is proposed for inclusion into draft monographs “Hellebore rhizomes with roots, tincture” and “Hellebore rhizomes with roots, tincture, solution for external use”.Conclusions: the developed test procedure can be used as an identification test for a range of products from the hellebore herbal substance to hellebore-based herbal medicinal products, which is based on the detection of the same group of biologically active substances.
摘要采用相同的检测方法对海棠(Veratrum Lobelianum Bernh.)草本物质以及以海棠为基础的草药制剂和草药制品进行同一组生物活性物质的鉴定，符合所谓的“一致性标准化”原则。本研究的目的是开发一种统一的方法来鉴定嚏根草产品(嚏根草水、嚏根草酊剂)和嚏根草草本物质(有根的嚏根草)中的甾体生物碱。材料和方法:采用高效薄层色谱法(HPTLC)对大黄水、大黄酊和带根大黄根茎样品进行分析。结果:基于甾体生物碱的HPTLC检测，作者制定了一套统一的含根helheltem制剂(草药物质、草药制剂和草药产品)的鉴定程序。本研究结果将用于准备对专著FS.2.5.0104.18“Hellebore rhizomes with roots”鉴定部分的修订。所开发的测试程序被建议纳入专着草案“带根、酊剂的嚏根草”和“带根、酊剂、外用溶液的嚏根草”。结论:所建立的检测程序可作为基于同一组生物活性物质检测的一系列产品的鉴定试验，从helhelle herbal substance到helhelle based herbal medicinal products。
{"title":"Improvement of Methods of Standardisation of Medicinal Products Made from Veratrum Lobelianum Rhizomes with Roots","authors":"N. Antonova, I. M. Morgunov, S. S. Prokhvatilova, E. Shefer, O. Evdokimova, A. Beketova, M. N. Lyakina","doi":"10.30895/10.30895/1991-2919-2021-11-1-44-48","DOIUrl":"https://doi.org/10.30895/10.30895/1991-2919-2021-11-1-44-48","url":null,"abstract":"Abstract. Identification of hellebore (Veratrum Lobelianum Bernh.) herbal substance, as well as hellebore-based herbal preparation and herbal medicinal product by the same group of biologically active substances using the same test method is in line with the so-called “consistent standardisation” principle.The aim of the study was to develop a harmonised approach to identification of steroidal alkaloids in hellebore products (hellebore water, hellebore tincture) and hellebore herbal substance (hellebore rhizomes with roots).Materials and methods: samples of hellebore water, hellebore tincture, and hellebore rhizomes with roots were analysed by high-performance thin-layer chromatography (HPTLC) using an HPTLC plate.Results: the authors developed a harmonised identification procedure for products made from hellebore rhizomes with roots (herbal substance, herbal preparation, and herbal medicinal product) based on HPTLC detection of steroidal alkaloids. The results of the study will be used to prepare amendments to the Identification part of monograph FS.2.5.0104.18 “Hellebore rhizomes with roots”. The developed test procedure is proposed for inclusion into draft monographs “Hellebore rhizomes with roots, tincture” and “Hellebore rhizomes with roots, tincture, solution for external use”.Conclusions: the developed test procedure can be used as an identification test for a range of products from the hellebore herbal substance to hellebore-based herbal medicinal products, which is based on the detection of the same group of biologically active substances.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83735421","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}
Pub Date : 2021-03-10DOI: 10.30895/1991-2919-2021-11-1-36-43
N. Antonova, E. Shefer, N. E. Semenova, S. S. Prokhvatilova, A. Kalinin, S. A. Kuchugurin, V. N. Makukhin
Abstract. Papaverine hydrochloride products are used as anticonvulsants in routine medical practice. Most of the approved product specification files include thin-layer chromatography for assessment of product-related impurities and UV spectrophotometry for determination of active pharmaceutical ingredients. An HPLC assay is not used for determination of papaverine hydrochloride in drug dosage forms.The aim of the study was to develop an HPLC test method for determination of product-related impurities and for quantification of papaverine hydrochloride in solutions for injection, tablets, and rectal suppositories.Materials and methods: samples of the following Russian-made papaverine products were used in the study: Papaverine, solution for injection, 20 mg/mL; Papaverine, rectal suppositories, 20 mg; Papaverine, tablets, 40 mg. The Agilent 1260 Infinity II DAD System was used for the HPLC assay, and the Agilent 8453Е UV-Vis System was used for recording UV spectra. The determination of product-related impurities and the assay of active ingredients were performed simultaneously by HPLC using a reversed-phase column Kromasil 100-5-C18, 250×4.6 mm, 5 μm, the gradient elution mode, and detection at 238 nm. Papaverine Hydrochloride USP RS, 99% purity, and Noscapine EP CRS were used as reference standards.Results: the study demonstrated that determination of product-related impurities and assay of active ingredients in papaverine products can be performed simultaneously using HPLC.Conclusions: the authors proposed an HPLC test method for determination of active ingredients in papaverine products, which is aligned with the “consistent standardisation” principle and can be recommended for inclusion into draft monographs for papaverine products.
摘要盐酸罂粟碱产品在常规医疗实践中用作抗惊厥药。大多数批准的产品规格文件包括用于评估产品相关杂质的薄层色谱法和用于测定活性药物成分的紫外分光光度法。HPLC法不用于药物剂型中盐酸罂粟碱的测定。本研究的目的是建立一种高效液相色谱法测定产品相关杂质和定量盐酸罂粟碱注射液、片剂和直肠栓剂溶液的方法。材料和方法:本研究采用俄罗斯产罂粟碱制品样品:罂粟碱，注射用溶液，20 mg/mL;罂粟碱直肠栓剂，20毫克;罂粟碱，片剂，40毫克采用Agilent 1260 Infinity II DAD系统进行HPLC分析，使用Agilent 8453Е UV- vis系统记录紫外光谱。采用HPLC法，反相柱Kromasil 100-5-C18, 250×4.6 mm, 5 μm，梯度洗脱，238 nm检测，同时进行产品相关杂质的测定和有效成分的测定。以盐酸罂粟碱USP RS(纯度99%)和诺斯卡平EP RS(纯度99%)为标准品。结果:采用高效液相色谱法可同时测定罂粟碱制品中的产品相关杂质和有效成分。结论:提出了一种高效液相色谱法测定罂粟碱产品中有效成分的方法，该方法符合“一致性标准化”原则，可推荐纳入罂粟碱产品专著草案。
{"title":"Development of a Comprehensive HPLC Method for Determination of Product-related Impurities and Assay of Active Ingredients in Papaverine Hydrochloride Products","authors":"N. Antonova, E. Shefer, N. E. Semenova, S. S. Prokhvatilova, A. Kalinin, S. A. Kuchugurin, V. N. Makukhin","doi":"10.30895/1991-2919-2021-11-1-36-43","DOIUrl":"https://doi.org/10.30895/1991-2919-2021-11-1-36-43","url":null,"abstract":"Abstract. Papaverine hydrochloride products are used as anticonvulsants in routine medical practice. Most of the approved product specification files include thin-layer chromatography for assessment of product-related impurities and UV spectrophotometry for determination of active pharmaceutical ingredients. An HPLC assay is not used for determination of papaverine hydrochloride in drug dosage forms.The aim of the study was to develop an HPLC test method for determination of product-related impurities and for quantification of papaverine hydrochloride in solutions for injection, tablets, and rectal suppositories.Materials and methods: samples of the following Russian-made papaverine products were used in the study: Papaverine, solution for injection, 20 mg/mL; Papaverine, rectal suppositories, 20 mg; Papaverine, tablets, 40 mg. The Agilent 1260 Infinity II DAD System was used for the HPLC assay, and the Agilent 8453Е UV-Vis System was used for recording UV spectra. The determination of product-related impurities and the assay of active ingredients were performed simultaneously by HPLC using a reversed-phase column Kromasil 100-5-C18, 250×4.6 mm, 5 μm, the gradient elution mode, and detection at 238 nm. Papaverine Hydrochloride USP RS, 99% purity, and Noscapine EP CRS were used as reference standards.Results: the study demonstrated that determination of product-related impurities and assay of active ingredients in papaverine products can be performed simultaneously using HPLC.Conclusions: the authors proposed an HPLC test method for determination of active ingredients in papaverine products, which is aligned with the “consistent standardisation” principle and can be recommended for inclusion into draft monographs for papaverine products.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"76 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83380046","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}
Pub Date : 2021-01-01DOI: 10.30895/1991-2919-2021-11-1-49-54
N. E. Kuz’mina, S. Moiseev, B. Romanov
Near-infrared spectrometry (NIRS) is a new pharmacopoeial method. It is widely used in the pharmaceutical industry for quality control of medicinal products at various production stages (control of raw materials and finished products), and for detection of substandard and counterfeit drugs.The aim of the study was to assess the feasibility of using NIRS as an identification test for active ingredients during pre-marketing quality control of medicinal products.Materials and methods: 327 drugs samples represented as solid and semisolid dosage forms were tested by NIRS following their examination by well-established pharmacopoeial Identification methods during pre-marketing laboratory evaluation. The NIR spectra of the test samples were compared with the spectral library classification models.Results: NIRS confirmed the identity of 3.1% of the tested medicinal products. It was demonstrated that library classification models could be used for identification of only those medicines that were produced by a specific manufacturer, i.e. for confirmation of medicine identity.Conclusions: the NIRS method is unpractical as an Identification test for active ingredients in medicinal products during the pre-marketing laboratory evaluation stage. The main limitations of NIRS are lack of complete sets of library classification models for all medicinal products available in the market and non-reproducibility of spectral library data obtained with a different instrument.
{"title":"Limitations of NIR Spectrometry as an Identification Test for Active Ingredients in Medicinal Products","authors":"N. E. Kuz’mina, S. Moiseev, B. Romanov","doi":"10.30895/1991-2919-2021-11-1-49-54","DOIUrl":"https://doi.org/10.30895/1991-2919-2021-11-1-49-54","url":null,"abstract":"Near-infrared spectrometry (NIRS) is a new pharmacopoeial method. It is widely used in the pharmaceutical industry for quality control of medicinal products at various production stages (control of raw materials and finished products), and for detection of substandard and counterfeit drugs.The aim of the study was to assess the feasibility of using NIRS as an identification test for active ingredients during pre-marketing quality control of medicinal products.Materials and methods: 327 drugs samples represented as solid and semisolid dosage forms were tested by NIRS following their examination by well-established pharmacopoeial Identification methods during pre-marketing laboratory evaluation. The NIR spectra of the test samples were compared with the spectral library classification models.Results: NIRS confirmed the identity of 3.1% of the tested medicinal products. It was demonstrated that library classification models could be used for identification of only those medicines that were produced by a specific manufacturer, i.e. for confirmation of medicine identity.Conclusions: the NIRS method is unpractical as an Identification test for active ingredients in medicinal products during the pre-marketing laboratory evaluation stage. The main limitations of NIRS are lack of complete sets of library classification models for all medicinal products available in the market and non-reproducibility of spectral library data obtained with a different instrument.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81460946","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}
Pub Date : 2021-01-01DOI: 10.30895/1991-2919-2021-11-1-24-35
V. Kosman, N. Faustova, M. V. Karlina, V. Makarov, M. Makarova
Medicinal products of natural origin are widely used by virtue of their pharmacological efficacy and relative safety. Chemical composition of such medicines is usually complex, they may be represented by heteropolymers or mixtures containing peptides, polysaccharides, and other compounds which are endogenous and/or rapidly metabolised in a living organism. Conventional, chromatography-based approaches to evaluation of such medicines are often not applicable. Pharmacokinetics of medicinal products of natural origin may be studied by methods based on assessment of biological action and pharmacodynamic properties of such medicines, which involves determination of biological marker (biomarker) levels. The aim of the study was to summarise the accumulated experimental data on the use of biomarkers in pharmacokinetics studies as illustrated by a few medicinal products of natural origin. Material and methods. The authors studied fucoidan from Fucus vesiculosus, as well as a complex of bioactive compounds and a glycopeptide—both isolated from gonads of green sea urchins (Strongylocentrotus droebachiensis). In vitro / ex vivo experiments were used to establish correlation between the concentrations of the test mixtures and the activity/ concentration of potential biomarkers. Experiments showing the biomarker concentration in plasma or serum (in vitro) and whole blood (ex vivo) before and after spiking with the studied products were performed in order to assess specificity, calibration (linear) range of the biomarker response, and its native concentration. The analytical procedures were based on the chromogenic (optical) anti-factor Xa activity (AXA) assay, and determination of dipeptidyl peptidase 4 and lactate dehydrogenase activity by kinetic
{"title":"Use of Biomarkers in Pharmacokinetics Studies of Medicinal Products of Natural Origin","authors":"V. Kosman, N. Faustova, M. V. Karlina, V. Makarov, M. Makarova","doi":"10.30895/1991-2919-2021-11-1-24-35","DOIUrl":"https://doi.org/10.30895/1991-2919-2021-11-1-24-35","url":null,"abstract":"Medicinal products of natural origin are widely used by virtue of their pharmacological efficacy and relative safety. Chemical composition of such medicines is usually complex, they may be represented by heteropolymers or mixtures containing peptides, polysaccharides, and other compounds which are endogenous and/or rapidly metabolised in a living organism. Conventional, chromatography-based approaches to evaluation of such medicines are often not applicable. Pharmacokinetics of medicinal products of natural origin may be studied by methods based on assessment of biological action and pharmacodynamic properties of such medicines, which involves determination of biological marker (biomarker) levels. The aim of the study was to summarise the accumulated experimental data on the use of biomarkers in pharmacokinetics studies as illustrated by a few medicinal products of natural origin. Material and methods. The authors studied fucoidan from Fucus vesiculosus, as well as a complex of bioactive compounds and a glycopeptide—both isolated from gonads of green sea urchins (Strongylocentrotus droebachiensis). In vitro / ex vivo experiments were used to establish correlation between the concentrations of the test mixtures and the activity/ concentration of potential biomarkers. Experiments showing the biomarker concentration in plasma or serum (in vitro) and whole blood (ex vivo) before and after spiking with the studied products were performed in order to assess specificity, calibration (linear) range of the biomarker response, and its native concentration. The analytical procedures were based on the chromogenic (optical) anti-factor Xa activity (AXA) assay, and determination of dipeptidyl peptidase 4 and lactate dehydrogenase activity by kinetic","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"413 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79987122","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}
Pub Date : 2021-01-01DOI: 10.30895/1991-2919-2021-11-1-6-15
D. P. Romodanovsky, A. Khokhlov, D. Goryachev
The coronavirus (COVID-19) pandemic, which began in 2020, has affected all spheres of life, including clinical trial processes. Health authorities around the world issued recommendations aimed at minimising the risks of virus spreading and ensuring the safety of study participants. One of the types of clinical trials is bioequivalence studies of generic medicines. The aim of the study was to analyse current foreign approaches to planning and conduct of bioequivalence studies of medicines in the context of the COVID-19 pandemic, and to develop recommendations for planning of studies conducted in the Eurasian Economic Union and evaluation of their results. The paper discusses the main provisions of the current guidelines of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on the planning, conduct and evaluation of clinical trials and, in particular, bioequivalence studies of generic medicines. The paper substantiates the necessity of detailing the recommendations of the Ministry of Health of the Russian Federation, published in an open letter to all market stakeholders and regulating the conduct of clinical trials of medicines in the context of the coronavirus pandemic. The results of the analysis helped to develop recommendations aimed at ensuring the protection of clinical trial participants, as well as maintaining an acceptable level of quality and reliability of study results.
{"title":"Planning Bioequivalence Studies in the Context of the COVID-19 Pandemic","authors":"D. P. Romodanovsky, A. Khokhlov, D. Goryachev","doi":"10.30895/1991-2919-2021-11-1-6-15","DOIUrl":"https://doi.org/10.30895/1991-2919-2021-11-1-6-15","url":null,"abstract":"The coronavirus (COVID-19) pandemic, which began in 2020, has affected all spheres of life, including clinical trial processes. Health authorities around the world issued recommendations aimed at minimising the risks of virus spreading and ensuring the safety of study participants. One of the types of clinical trials is bioequivalence studies of generic medicines. The aim of the study was to analyse current foreign approaches to planning and conduct of bioequivalence studies of medicines in the context of the COVID-19 pandemic, and to develop recommendations for planning of studies conducted in the Eurasian Economic Union and evaluation of their results. The paper discusses the main provisions of the current guidelines of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on the planning, conduct and evaluation of clinical trials and, in particular, bioequivalence studies of generic medicines. The paper substantiates the necessity of detailing the recommendations of the Ministry of Health of the Russian Federation, published in an open letter to all market stakeholders and regulating the conduct of clinical trials of medicines in the context of the coronavirus pandemic. The results of the analysis helped to develop recommendations aimed at ensuring the protection of clinical trial participants, as well as maintaining an acceptable level of quality and reliability of study results.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"465 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82186387","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}
Pub Date : 2020-12-11DOI: 10.30895/1991-2919-2020-10-4-228-235
N. Tereshina, M. N. Lyakina, O. Naumova
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.
{"title":"Sea Water-Based Medicines: Manufacturing Technology and Standardisation","authors":"N. Tereshina, M. N. Lyakina, O. Naumova","doi":"10.30895/1991-2919-2020-10-4-228-235","DOIUrl":"https://doi.org/10.30895/1991-2919-2020-10-4-228-235","url":null,"abstract":"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.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85926982","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}
Pub Date : 2020-12-11DOI: 10.30895/1991-2919-2020-10-4-267-272
I. A. Buylova, O. Gunar
Validation/verification of microbiological methods is a prerequisite for quality control of non-sterile drugs. However, the use of existing procedures for validation/verification of analytical methods is challenging, since a number of factors, such as microorganism distribution in the sample, cell morphology, and metabolic activity of microorganisms contribute to the error in microbiological testing.The aim of the study was to assess the feasibility of using the microbiological method validation parameters for validation/verification of the agar plate method.Materials and methods: 18 non-sterile medicinal products were used in the study. Experiments included determination of antimicrobial activity. The quantification of viable bacteria, yeasts and moulds was performed using the modified pour plate method. The statistical processing of the obtained results was performed using Microsoft Excel 7.0 and Statistica 8.0.Results: the paper provides the results of quantitative determination of test microorganisms inoculated into non-sterile drugs. The results were obtained as part of validation/verification of the agar plate method of the State Pharmacopoeia of the Russian Federation, XIV ed.Conclusions: the validation/verification of the test method for isolation and quantification of microorganisms revealed no deviations of the study results from the established acceptance criteria. This proves the feasibility of using the following validation parameters: accuracy, precision, robustness, and limit of quantitation when validating new methods for quantitative determination of microorganisms or verification of previously validated methods.
{"title":"Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products","authors":"I. A. Buylova, O. Gunar","doi":"10.30895/1991-2919-2020-10-4-267-272","DOIUrl":"https://doi.org/10.30895/1991-2919-2020-10-4-267-272","url":null,"abstract":"Validation/verification of microbiological methods is a prerequisite for quality control of non-sterile drugs. However, the use of existing procedures for validation/verification of analytical methods is challenging, since a number of factors, such as microorganism distribution in the sample, cell morphology, and metabolic activity of microorganisms contribute to the error in microbiological testing.The aim of the study was to assess the feasibility of using the microbiological method validation parameters for validation/verification of the agar plate method.Materials and methods: 18 non-sterile medicinal products were used in the study. Experiments included determination of antimicrobial activity. The quantification of viable bacteria, yeasts and moulds was performed using the modified pour plate method. The statistical processing of the obtained results was performed using Microsoft Excel 7.0 and Statistica 8.0.Results: the paper provides the results of quantitative determination of test microorganisms inoculated into non-sterile drugs. The results were obtained as part of validation/verification of the agar plate method of the State Pharmacopoeia of the Russian Federation, XIV ed.Conclusions: the validation/verification of the test method for isolation and quantification of microorganisms revealed no deviations of the study results from the established acceptance criteria. This proves the feasibility of using the following validation parameters: accuracy, precision, robustness, and limit of quantitation when validating new methods for quantitative determination of microorganisms or verification of previously validated methods.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87272458","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}
Pub Date : 2020-12-11DOI: 10.30895/1991-2919-2020-10-4-218-227
E. L. Kovaleva, V. V. Shelestova, L. N. Frolova, O. Bondarenko, O. Nikolaeva, V. Y. Kuteynikov
The introduction of monographs on new types of herbal substances, which were not included in the previous editions of the State Pharmacopoeia of the Russian Federation (Ph. Rus.), and the introduction of the new powder dosage form of herbal medicinal products require alignment of requirements for the degree of fineness of medicinal products. The aim of the study was to compare Russian and foreign pharmacopoeial requirements for the degree of fineness of herbal substances and herbal medicinal products. The analysis demonstrated that in the case of cut herbal substances and powder, the Ph. Rus., XIV edition, establishes limits for the percent of particles that pass through and particles that are retained by a sieve with a specified pore diameter. In the case of whole herbal substances, the Ph. Rus. establishes limits for the percent of particles that pass through a sieve with a specified pore diameter. The monographs of the world leading pharmacopoeias include general requirements for the size of particles in all powders produced from chemically synthesized substances, as well as from naturally occurring and mineral substances, while individual monographs have no requirements for the degree of fineness of herbal substances. The national pharmacopoeias of the Eurasian Economic Union member states also include requirements for the degree of fineness of herbal substances, but they are not sufficient. The results of the analysis of the established limits demonstrate the need to change the controlled size of small and large particles for some types of herbal substances.
{"title":"Current Requirements for the Degree of Fineness of Herbal Substances and Herbal Medicinal Products","authors":"E. L. Kovaleva, V. V. Shelestova, L. N. Frolova, O. Bondarenko, O. Nikolaeva, V. Y. Kuteynikov","doi":"10.30895/1991-2919-2020-10-4-218-227","DOIUrl":"https://doi.org/10.30895/1991-2919-2020-10-4-218-227","url":null,"abstract":"The introduction of monographs on new types of herbal substances, which were not included in the previous editions of the State Pharmacopoeia of the Russian Federation (Ph. Rus.), and the introduction of the new powder dosage form of herbal medicinal products require alignment of requirements for the degree of fineness of medicinal products. The aim of the study was to compare Russian and foreign pharmacopoeial requirements for the degree of fineness of herbal substances and herbal medicinal products. The analysis demonstrated that in the case of cut herbal substances and powder, the Ph. Rus., XIV edition, establishes limits for the percent of particles that pass through and particles that are retained by a sieve with a specified pore diameter. In the case of whole herbal substances, the Ph. Rus. establishes limits for the percent of particles that pass through a sieve with a specified pore diameter. The monographs of the world leading pharmacopoeias include general requirements for the size of particles in all powders produced from chemically synthesized substances, as well as from naturally occurring and mineral substances, while individual monographs have no requirements for the degree of fineness of herbal substances. The national pharmacopoeias of the Eurasian Economic Union member states also include requirements for the degree of fineness of herbal substances, but they are not sufficient. The results of the analysis of the established limits demonstrate the need to change the controlled size of small and large particles for some types of herbal substances.","PeriodicalId":22286,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78075510","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}
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