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Recommendations for the Programme of Clinical Trials of Medicinal Products for the Treatment of Influenza 关于治疗流感的药品临床试验规划的建议
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-18 DOI: 10.30895/1991-2919-2022-400
A. Gubenko, G. V. Shukshina, A. I. Muravieva, N. E. Uvarova
{"title":"Recommendations for the Programme of Clinical Trials of Medicinal Products for the Treatment of Influenza","authors":"A. Gubenko, G. V. Shukshina, A. I. Muravieva, N. E. Uvarova","doi":"10.30895/1991-2919-2022-400","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-400","url":null,"abstract":"The development of new medicinal products to treat influenza is motivated by the limitations of existing treatment options, the emergence of drug resistance, and the health consequences of influenza epidemics associated with the highly contagious nature of the virus. Proper planning and implementation of clinical programmes providing reliable data on the efficacy and safety of medicinal products under development requires adherence to recommendations of the regulatory authorities. At the moment, the Russian Federation, the Eurasian Economic Union, and the European Union lack documented recommendations on conducting clinical trials of anti-influenza medicines. There is a need in national guidelines that will reflect the procedure for conducting clinical trials and establish the required amount of data to be submitted with marketing applications for new anti-influenza products. The aim of this study was to analyse possible regulatory approaches to planning clinical development programmes for anti-influenza medicinal products. The article pays particular attention to phase III studies, as the main studies confirming efficacy and safety. The authors described a clinical development strategy and the requirements for the volume and quality of efficacy and safety data. This article is based on the current Russian recommendations for the design and development of medicinal products and guidelines on their evaluation, as well as the recommendations by the U.S. Food and Drug Administration (FDA). The analysis results demonstrate the necessity for elaborating Russian recommendations for clinical studies of medicinal products for the treatment of influenza that will take into account the national legislation and clinical development practices. Such recommendations will streamline the implementation of new effective anti-influenza medicinal products.","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122720361","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}
引用次数: 0
Nasolacrimal Duct Obstruction Secondary to Radioactive Iodine-131 Therapy for Differentiated Thyroid Cancer 放射性碘-131治疗分化型甲状腺癌继发鼻泪管阻塞
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-11 DOI: 10.30895/1991-2919-2022-12-4-415-424
A. Trukhin, V. Yartsev, M. S. Sheremeta, D. Yudakov, M. Korchagina, R. Salimkhanov, S. V. Grishkov
{"title":"Nasolacrimal Duct Obstruction Secondary to Radioactive Iodine-131 Therapy for Differentiated Thyroid Cancer","authors":"A. Trukhin, V. Yartsev, M. S. Sheremeta, D. Yudakov, M. Korchagina, R. Salimkhanov, S. V. Grishkov","doi":"10.30895/1991-2919-2022-12-4-415-424","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-415-424","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115916188","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}
引用次数: 1
Regulation of Radiopharmaceutical Products 放射性药物制品的规管
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-03 DOI: 10.30895/1991-2919-2022-12-4-379-388
V. Kosenko, A. Trapkova, S. Kalmykov
{"title":"Regulation of Radiopharmaceutical Products","authors":"V. Kosenko, A. Trapkova, S. Kalmykov","doi":"10.30895/1991-2919-2022-12-4-379-388","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-379-388","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130443962","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}
引用次数: 0
Potential of Theranostics in Visualisation of the Tumour Microenvironment and Elimination of Its Immunosuppressive Components 肿瘤微环境可视化和消除其免疫抑制成分的治疗学潜力
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-03 DOI: 10.30895/1991-2919-2022-12-4-425-443
O. Molchanov, D. Maystrenko, A. Stanzhevskiy
{"title":"Potential of Theranostics in Visualisation of the Tumour Microenvironment and Elimination of Its Immunosuppressive Components","authors":"O. Molchanov, D. Maystrenko, A. Stanzhevskiy","doi":"10.30895/1991-2919-2022-12-4-425-443","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-425-443","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125185327","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}
引用次数: 0
18F-FDG PET/CT in the Diagnosis of Cervical Cancer 18F-FDG PET/CT在宫颈癌诊断中的价值
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-03 DOI: 10.30895/1991-2919-2022-12-4-444-454
A. Leontyev, M. M. Khodzhibekova, A. Khalimon, M. Т. Kuliev, G. F. Khamadeeva, T. L. Antonevskaya, T. N. Lazutina, A. Kaprin
{"title":"18F-FDG PET/CT in the Diagnosis of Cervical Cancer","authors":"A. Leontyev, M. M. Khodzhibekova, A. Khalimon, M. Т. Kuliev, G. F. Khamadeeva, T. L. Antonevskaya, T. N. Lazutina, A. Kaprin","doi":"10.30895/1991-2919-2022-12-4-444-454","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-444-454","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130137478","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}
引用次数: 0
Features and Practical Aspects of Radiochemical Purity Determination of Receptor-Specific Lu-177 Radiopharmaceuticals as Exemplified by [177Lu]Lu–PSMA-617 以[177Lu] Lu-PSMA-617为例的受体特异性放射性药物Lu-177放射化学纯度测定的特点及实用意义
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-02 DOI: 10.30895/1991-2919-2022-12-4-455-467
A. Larenkov, Y. Mitrofanov, M. G. Rakhimov
{"title":"Features and Practical Aspects of Radiochemical Purity Determination of Receptor-Specific Lu-177 Radiopharmaceuticals as Exemplified by [177Lu]Lu–PSMA-617","authors":"A. Larenkov, Y. Mitrofanov, M. G. Rakhimov","doi":"10.30895/1991-2919-2022-12-4-455-467","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-455-467","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"84 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126407101","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}
引用次数: 2
Pharmacokinetic Studies of Radiopharmaceuticals 放射性药物的药代动力学研究
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-11-02 DOI: 10.30895/1991-2919-2022-12-4-395-403
A. Lunev, K. Lunyova, O. Klementyeva
{"title":"Pharmacokinetic Studies of Radiopharmaceuticals","authors":"A. Lunev, K. Lunyova, O. Klementyeva","doi":"10.30895/1991-2919-2022-12-4-395-403","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-395-403","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125523162","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}
引用次数: 0
Radioactivity distribution in the blood and urine of patients receiving systemic therapy with a 177Lu radiopharmaceutical and local (intra-articular) therapy with a 188Re radiopharmaceutical 接受177Lu放射药物全身治疗和188Re放射药物局部(关节内)治疗的患者血液和尿液中的放射性分布
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-10-25 DOI: 10.30895/1991-2919-2022-12-4-404-414
E. Stepchenkova, V. Tishchenko, O. Vlasova, V. Petriev, N. Legkodimova, V. Krylov, A. V. Fedorova, E. A. Kuzenkova, A. A. Ostroukhoff, P. Shegai
{"title":"Radioactivity distribution in the blood and urine of patients receiving systemic therapy with a 177Lu radiopharmaceutical and local (intra-articular) therapy with a 188Re radiopharmaceutical","authors":"E. Stepchenkova, V. Tishchenko, O. Vlasova, V. Petriev, N. Legkodimova, V. Krylov, A. V. Fedorova, E. A. Kuzenkova, A. A. Ostroukhoff, P. Shegai","doi":"10.30895/1991-2919-2022-12-4-404-414","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-404-414","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"111 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134499418","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}
引用次数: 0
Peculiarities of the Regulatory Status of Radiopharmaceuticals Manufactured in Medical Organisations 医疗机构生产的放射性药物监管状况的特点
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-10-18 DOI: 10.30895/1991-2919-2022-12-4-389-394
S. Shatik, D. Maystrenko, A. Stanzhevskiy
{"title":"Peculiarities of the Regulatory Status of Radiopharmaceuticals Manufactured in Medical Organisations","authors":"S. Shatik, D. Maystrenko, A. Stanzhevskiy","doi":"10.30895/1991-2919-2022-12-4-389-394","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-389-394","url":null,"abstract":"","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126554880","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}
引用次数: 0
“We should strive to attain Russia’s former standing in nuclear medicine” “我们应该努力恢复俄罗斯以前在核医学领域的地位”
The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation Pub Date : 2022-10-18 DOI: 10.30895/1991-2919-2022-12-4-356-358
S. N. Kalmykov
{"title":"“We should strive to attain Russia’s former standing in nuclear medicine”","authors":"S. N. Kalmykov","doi":"10.30895/1991-2919-2022-12-4-356-358","DOIUrl":"https://doi.org/10.30895/1991-2919-2022-12-4-356-358","url":null,"abstract":"<jats:p>.</jats:p>","PeriodicalId":366540,"journal":{"name":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation","volume":"478 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114016420","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}
引用次数: 0
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