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regulatory science promotes the translation of transcatheter tricuspid valve repair/replacement devices

Regenerative Biomaterials 2024年第6期3卷 42-49页

作者： Maobo Cheng Yun Xu Wei Liu Lanlan Mu Xiaoqi Lian Guobiao Gao Lei Sun Center for Medical Device Evaluation National Medical Products AdministrationBeijing 100081China Guangdong-Hong Kong-Macao Greater Bay Area Center for Medical Device Evaluation and Inspection of NMPAShenzhen 518045China

For patients with symptomatic and severe tricuspid regurgitation but inoperable with open surgery,transcatheter tricuspid valve intervention(TTVI)is a procedure of great clinical *** products include repair and replacement *** products are one of the hotspots of investigation now,with different inno-vative biomaterials and structural designs in trials to satisfy di-vergent indications and reduce *** the emerging biomaterials,the technical difficulty of structural design will be greatly reduced,spurring further product innovation and *** innovativeness and complexity of TTVI products have brought challenges to academia,industry,and regulatory *** science provides a bridge to address these difficulties and *** perspective article introduces the latest development of the TTVI *** traditional methods,regulatory agencies face challenges in evaluating the safety and effi-cacy of TTVr/TTVR devices given the uncertainty of clinical use and the diversity of innovative structural *** perspective article analyzes the regulatory challenges and discusses regulatory science that can be developed to assess the safety,efficacy,quality and performance of such products:including new approaches for innovative devices,pre-review path,computer modeling and simulation,accelerated wear testing methods for transcatheter heart valves and evidence-based *** article reveals for the first time how to apply regulatory science systematically to TTVI products,which is of great relevance to their development and translation.

关键词： transcatheter interventional products transcatheter tricuspid valve repair devices transcatheter tricuspid valve replacement devices regulatory science translation

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regulatory science for hernia mesh: Current status and future perspectives

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Bioactive Materials 2021年第2期6卷 420-432页

作者： Wenbo Liu Yajie Xie Yudong Zheng Wei He Kun Qiao Haoye Meng School of Material science and Engineering University of Science and Technology Beijing30 Xueyuan RoadHaidian DistrictBeijingChina Center for Medical Device Evaluation National Medical Products AdministrationIntellectual Property Publishing House MansionQixiang RoadHaidian DistrictBeijingChina

regulatory science for medical devices aims to develop new tools,standards and approaches to assess the safety,effectiveness,quality and performance of medical *** the field of biomaterials,hernia mesh is a class of implants that have been successfully translated to clinical *** a focus on hernia mesh and its regulatory science system,this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American *** current development of regulatory science for hernia mesh,including its regulations,standards,guidance documents and classification,and the scientific evaluation of its safety and effectiveness was first *** the research prospect of regulatory science for hernia mesh was *** methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh,such as computational modeling,big data platform and evidence-based research,were *** taking the regulatory science of hernia mesh as a case study,this review provided a research basis for developing a regulatory science system of implantable medical devices,furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory *** was the first article reviewing the regulatory science of hernia mesh and biomaterial-based *** also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.

关键词： regulatory science Safety and effectiveness Hernia mesh Regeneration Remolding

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Biomaterials and regulatory science

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Journal of Materials science & Technology 2022年第33期128卷 221-227页

作者： Xu Song Zhonglan Tang Wenbo Liu Kuan Chen Jie Liang Bo Yuan Hai Lin Xiangdong Zhu Yujiang Fan Xinli Shi Peng Zhao Lei Yang Kai Zhang Antonios G.Mikos Xingdong Zhang Institute of regulatory science for Medical Devices Sichuan UniversityChengdu 610064China National Engineering Research Center for Biomaterials Sichuan UniversityChengdu 610064China School of Biomedical Engineering Sichuan UniversityChengdu 610064China Center for Medical Device Evaluation National Medical Products AdministrationBeijing 100081China Sichuan Testing Center for Biomaterials and Medical Devices Chengdu 610064China Center for Health sciences and Engineering School of Health Sciences and Biomedical EngineeringHebei University of TechnologyTianjin 300130China Departments of Bioengineering Chemical and Biomolecular EngineeringRice UniversityHoustonTX 77251USA

The fast development of both biomaterials and regulatory science calls for a convergence,which is addressed in this article via their link through medical products of biomaterials and related safety and efficacy *** updated definition of biomaterials,and concepts of biomaterials-related medical products and so-called medical-grade and implantable materials are firstly *** a brief overview of the concept and history of regulatory science and its assessment of safety and efficacy of medical products,as well as the currently ongoing biomaterials-related regulatory science programs are ***,the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are *** the first article in the field to elucidate the relationship between biomaterials and regulatory science,key take-home messages include(1)biomaterials alone are not medical products;(2)regulatory authorities approve/clear final medical products,not biomaterials;(3)there is no definition/regulation on the so-called medical-grade or implantable materials;and(4)safety and efficacy refer to final medical products,not biomaterials alone.

关键词： Biomaterials Medical products regulatory science Safety Efficacy

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Review on Drug regulatory science Promoting COVID-19 Vaccine Development in China

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Engineering 2022年第3期8卷 127-132页

作者： Zhiming Huang Zhihao Fu Junzhi Wang National Medical Products Administration Beijing 100053China National Institutes for Food and Drug Control Beijing 102629China

regulatory science is a discipline that uses comprehensive methods of natural science,social science,and humanities to provide support for administrative decision-making through the development of new tools,standards,and approaches to assess the safety,efficacy,quality,and performance of regulated *** the pandemics induced by infectious diseases,such as H1N1 flu,severe acute respiratory syndrome(SARS),and Middle East respiratory syndrome(MERS),regulatory science strongly supported the development of drugs and vaccines to respond to the *** particular,with the support of research on drug regulatory science,vaccines have played a major role in the prevention and control of coronavirus disease 2019(COVID-19).This review summarizes the overall state of the vaccine industry,research and development(R&D)of COVID-19 vaccines in China,and the general state of regulatory science and supervision for vaccines in ***,this review highlights how regulatory science has promoted the R&D of Chinese COVID-19 vaccines,with analyses from the aspects of nationallevel planning,relevant laws and regulations,technical guidelines,quality control platforms,and postmarketing ***,this review provides a reference for the formulation of a vaccine development strategy in response to the current pandemic and the field of vaccine development in the post-pandemic era,as well as guidance on how to better respond to emerging and recurring infectious diseases that may occur in the future.

关键词： regulatory science COVID-19 vaccine Vaccine industry

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Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics

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Journal of Pharmaceutical Analysis 2024年第6期14卷 785-804页

作者： Patanachai K.Limpikirati Sorrayut Mongkoltipparat Thinnaphat Denchaipradit Nathathai Siwasophonpong Wudthipong Pornnopparat Parawan Ramanandana Phumrapee Pianpaktr Songsak Tongchusak Maoxin Tim Tian Trairak Pisitkun Department of Food and Pharmaceutical Chemistry Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand Pharmaceutical sciences and Technology(PST)Graduate Program Faculty of Pharmaceutical SciencesChulalongkorn UniversityPathumwanBangkok10330Thailand Center of Excellence in Systems Biology(CUSB) Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand Department of Pharmaceutical Chemistry Faculty of Pharmaceutical SciencesHuachiew Chalermprakiet UniversityBang PhliSamut Prakan10540Thailand Division of Research Affairs Faculty of MedicineChulalongkorn UniversityPathumwanBangkok10330Thailand

In this review,we focus on providing basics and examples for each component of the protein therapeutic specifications to interested pharmacists and biopharmaceutical scientists with a goal to strengthen understanding in regulatory science and *** specifications comprise a list of important quality attributes for testing,references to use for test procedures,and appropriate acceptance criteria for the tests,and they are set up to ensure that when a drug product is administered to a patient,its intended therapeutic benefits and safety can be rendered *** of drug substance or drug product to the specifications is achieved by testing an article according to the listed tests and analytical methods and obtaining test results that meet the acceptance *** attributes are chosen to be tested based on their quality risk,and consideration should be given to the merit of the analytical methods which are associated with the acceptance criteria of the *** criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric *** in this work are related guidelines that support the biopharmaceutical specification setting,how to set the acceptance criteria,and examples of the quality attributes and the analytical methods from 60 articles and 23 pharmacopeial *** are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.

关键词： Biopharmaceutical analysis Biopharmaceutical quality control Biopharmaceutical specifications Monoclonal antibodies Protein therapeutics regulatory science

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Strategic Planning for Drug regulatory science in the United States and Its Enlightenments to China

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Asian Journal of Social Pharmacy 2023年第2期18卷 91-97页

作者： Chang Yingnan Gong Jingran Chang Senhao Chen Yuwen School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China

Objective To study the strategic planning of drug regulatory science,the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strategic planning of drug regulatory science in *** Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United *** and Conclusion Drawing on the US experience,China should set goals based on mission and vision and identify problems,knowledge gaps,and key areas,then concrete measures can be taken to advance regulatory science.

关键词： the United States drug regulatory science strategic planning

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The regulatory sciences for stem cell-based medicinal products

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Frontiers of Medicine 2014年第2期8卷 190-200页

作者： Bao-Zhu Yuan JunzhiWang National Institutes for Food and Drug Control Beijing 100050 China

Over the past few years, several new achievements have been made from stem cell studies, many of which have moved up from preclinical stages to early, or from early to middle or late, stages thanks to relatively safe profile and preliminary evidence of effectiveness. Moreover, some stem cell-based products have been approved for marketing by different national regulatory authorities. However, many critical issues associated mainly with incomplete understanding of stem cell biology and the relevant risk factors, and lack of effective regulations still exist and need to be urgently addressed, especially in countries where establishment of appropriate regulatory system just commenced. More relevantly, the stem cell regulatory sciences need to be established or improved to more effectively evaluate quality, safety and efficacy of stem cell products, and for building up the appropriate regulatory framework. In this review, we summarize some new achievements in stem cell studies, especially the preclinical and clinical studies, the existing regulations, and the associated challenges, and we then propose some considerations for improving stem cell regulatory sciences with a goal of promoting the steadfast growth of the well-regulated stem cell therapies abreast of evolvement of stem cell sciences and technologies.

关键词： stem cell-based medicinal products (SCMPs) stem cell therapy (SCT) safety effectiveness standards guidelines regulatory science

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Plain metallic biomaterials:opportunities and challenges

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Regenerative Biomaterials 2023年第1期10卷 140-147页

作者： Jiazhen Zhang Bao Zhai Jintao Gao Zheng Li Yufeng Zheng Minglong Ma Yongjun Li Kui Zhang Yajuan Guo Xinli Shi Bin Liu Guobiao Gao Lei Sun Center for Medical Device Evaluation National Medical Product AdministrationBeijing 100081China Guangdong-Hong Kong-Macao Greater Bay Area Center for Medical Device Evaluation and Inspection of NMPAShenzhen 518045China School of Materials science and Engineering Peking UniversityBeijing 100871China State Key Laboratory of Nonferrous Metals and Process GRINM Group Corporation Limited(General Research Institute for Nonferrous Metals)Beijing 100088China

The‘plainification of materials’has been conceptualized to promote the sustainable development of *** perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic biomaterials(PMBs)’with demonstrated research and application case studies of pure titanium with high strength and toughness,and biodegradable,fine-grained and high-purity ***,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory *** perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.

关键词： plainification metallic biomaterials regulatory science medical devices pure titanium high-purity magnesium

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Control strategy and methods for continuous direct compression processes

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Asian Journal of Pharmaceutical sciences 2021年第2期16卷 253-262页

作者： Yasuhiro Suzuki Hirokazu Sugiyama Manabu Kano Ryutaro Shimono Gosuke Shimada Ryoichi Furukawa Eichi Mano Keiichi Motoyama Tatsuo Koide Yasuhiro Matsui Kazuki Kurasaki Issei Takayama Shunin Hikage Noriko Katori Masahiko Kikuchi Hiroshi Sakai Yoshihiro Matsuda Formulation Technology Research Laboratories Daiichi Sankyo Co.Ltd.Kanagawa 254-0014Japan Department of Chemical System Engineering The University of TokyoTokyo 113-8656Japan Department of Systems science Kyoto UniversityKyoto 606-8501Japan CMC sciences Department Regulatory Affairs DivisionR&D DivisionJanssen Pharmaceutical K.K.Tokyo 101-0065Japan EuroTechno Ltd. Kanagawa 223-0057Japan Pharmaceutical Research Department Mitsubishi Tanabe Pharma CorporationOsaka 532-8505Japan Chemical Products CMC Regulatory Affairs Area Japan DevelopmentMSD K.K.Tokyo 102-8667Japan Graduate School of Pharmaceutical sciences Kumamoto UniversityKumamoto 862-0973Japan Division of Drugs National Institute of Health SciencesKawasaki 210-9501Japan Technology Research&Development Sumitomo Dainippon Pharma Co.Ltd.Osaka 564-0053Japan Formulation Development Department Chugai pharmaceutical Co.Ltd.Tokyo 115-8543Japan Office of New Drug IV Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan Office of Generic Drugs Pharmaceuticals and Medical Devices AgencyShin-Kasumigaseki Bldg.Tokyo 100-0013Japan KOKANDO Co. Ltd.Toyama 930-8580Japan Pharmaceuticals and Medical Devices Agency Shin-Kasumigaseki Bldg.Tokyo 100-0013Japan

We presented a control strategy for tablet manufacturing processes based on continuous direct *** work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in *** different items in the process,the component ratio and blended powder content were selected as the items requiring the control method specific to continuous manufacturing different from the conventional batch *** control and management of the Loss in Weight(LIW)feeder were deemed the most important,and the Residence Time Distribution(RTD)model were regarded effective for setting the control range and for controlling of the LIW *** on these ideas,the concept of process control using RTD was summarized.

关键词： Continuous manufacturing Solid drug products Process control Residence time distribution Loss in weight feeder regulatory science

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regulatory perspectives of combination products

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Bioactive Materials 2022年第4期7卷 492-503页

作者： Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang Center for Medical Device Evaluation National Medical Products AdministrationBeijingChina NMPA Key Laboratory for Quality Research and Control of Tissue Regenerative Biomaterial&Institute of regulatory science for Medical Devices&NMPA Research Base of regulatory science for Medical Devices Sichuan UniversityChengduChina National Engineering Research Center for Biomaterials&College of Biomedical Engineering Sichuan UniversityChengduChina Center for Drug Evaluation National Medical Products AdministrationBeijingChina

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological *** product research and development,clinical translation as well as regulatory evaluation of combination products are complex and *** review firstly introduced the origin,definition and designation of combination *** areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then *** and clinical evaluation of combination products was ***,the research prospect of regulatory science for combination products was *** tools of computational modeling and simulation,novel technologies such as artificial intelligence,needs of developing new standards,evidence-based research methods,new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety,efficacy,quality and performance of combination *** together,the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

关键词： Combination products Definition Designation Safety and efficacy regulatory science

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