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 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 compliance.Pharmaceutical 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 appropriately.Conformance 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 criteria.Quality 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 specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed 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 monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.展开更多
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 strat...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 China.Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States.Results 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.展开更多
Objective To sort out the focus areas of FDA’s scientific supervision and to achieve corresponding results,so as to provide some suggestions for the scientific research and innovation of drug supervision in China.Met...Objective To sort out the focus areas of FDA’s scientific supervision and to achieve corresponding results,so as to provide some suggestions for the scientific research and innovation of drug supervision in China.Methods In-depth research was carried out in the fields of safety evaluation tools,clinical trial innovation,new methods of product quality evaluation,information science and so on.Results and Conclusion The research foundation of drug supervision related technology in China is weak,and a systematic supervision system has not been formed.Learning from the scientific experience of drug supervision in the United States,we can promote the development of the focus areas of drug supervision in China.Besides,we should improve the standard management ability while perfecting the regulations and standards system.Lastly,we should establish a system for government and industry-university-research to realize the full-cycle supervision of drugs.展开更多
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,...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 products.During 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 viruses.In 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 China.Further,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 supervision.Ultimately,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.展开更多
Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by Eur...Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by European Medicines Agency(EMA)and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe.Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science,and the construction of academic system and discourse system of regulatory science were improved,which played a role in promoting the progress of European drug regulatory science.It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible.Besides,the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs.展开更多
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 ...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.展开更多
Regulatory science for medical devices aims to develop new tools,standards and approaches to assess the safety,effectiveness,quality and performance of medical devices.In the field of biomaterials,hernia mesh is a cla...Regulatory science for medical devices aims to develop new tools,standards and approaches to assess the safety,effectiveness,quality and performance of medical devices.In the field of biomaterials,hernia mesh is a class of implants that have been successfully translated to clinical applications.With 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 markets.The 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 reported.Then the research prospect of regulatory science for hernia mesh was discussed.New 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 assessed.By 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 decision-making.This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants.It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.展开更多
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 evalu...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 evaluation.The updated definition of biomaterials,and concepts of biomaterials-related medical products and so-called medical-grade and implantable materials are firstly introduced.Then 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 presented.Finally,the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are discussed.As 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.展开更多
Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to d...Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to deepen the reform of medical and health system.Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process,operation mode,practical significance and characteristics of the big data platform for FDA regulatory science,which would help China to establish a perfect big database.Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States.It is necessary to build data platforms in line with China’s national conditions through efforts in law,talents,standards,and other aspects.展开更多
We presented a control strategy for tablet manufacturing processes based on continuous direct compression.The work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory aut...We presented a control strategy for tablet manufacturing processes based on continuous direct compression.The work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in Japan.Among 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 manufacturing.The 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 feeder.Based on these ideas,the concept of process control using RTD was summarized.展开更多
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.The product research and...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.The product research and development,clinical translation as well as regulatory evaluation of combination products are complex and challenging.This review firstly introduced the origin,definition and designation of combination products.Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented.Preclinical and clinical evaluation of combination products was discussed.Lastly,the research prospect of regulatory science for combination products was described.New 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 products.Taken 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.展开更多
The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic bioma...The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This 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 magnesium.Then,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory aspects.Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.展开更多
Biodegradable metals are promising candidates for bone defect repair.With an evidence-based approach,this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal mo...Biodegradable metals are promising candidates for bone defect repair.With an evidence-based approach,this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal models for bone defect repair to explore their potential clinical translation.Animal studies on bone defect repair with biodegradable metals in comparison with other traditional biomaterials were reviewed.Data was carefully collected after identification of population,intervention,comparison,outcome,and study design(PICOS),and following the inclusion criteria of biodegradable metals in animal studies.30 publications on pure Mg,Mg alloys,pure Zn and Zn alloys were finally included after extraction from a collected database of 2543 publications.A qualitative systematic review and a quantitative meta-analysis were performed.Given the heterogeneity in animal model,anatomical site and critical size defect(CSD),biodegradable metals exhibited mixed effects on bone defect repair and degradation in animal studies in comparison with traditional non-degradable metals,biodegradable polymers,bioceramics,and autogenous bone grafts.The results indicated that there were limitations in the experimental design of the included studies,and quality of the evidence presented by the studies was very low.To enhance clinical translation of biodegradable metals,evidence-based research with data validity is needed.Future studies should adopt standardized experimental protocols in investigating the effects of biodegradable metals on bone defect repair with animal models.展开更多
Biodegradable metals hold promises for bone fracture repair.Their clinical translation requires pre-clinical evaluations including animal studies,which demonstrate the safety and performance of such materials prior to...Biodegradable metals hold promises for bone fracture repair.Their clinical translation requires pre-clinical evaluations including animal studies,which demonstrate the safety and performance of such materials prior to clinical trials.This evidence-based study investigates and analyzes the performance of bone fractures repair as well as degr adation properties of biodegradable metals in animal models.Data were carefully collected after identification of population,interventions,com-parisons,outcomes and study design,as well as inclusion criteria combining biodegradable metals and animal study.Twelve publications on pure Mg,Mg alloys and Zn alloys were finally included and reviewed after extraction from a collected database of 2122 publications.Compared to controls of traditional non-degradable metals or resorbable polymers,biodegradable metals showed mixed or contradictory outcomes of fracture repair and degradation in animal models.Although quantita-tive meta-analysis cannot be conducted because of the data heterogeneity,this systematic review revealed that the quality of evidence for biodegradable metals to repair bone fractures in animal models is'very low'.Recommendations to standardize the animal studies of biodegradable metals were proposed.Evidence based biomaterials research could help to both identify reliable scientific evidence and ensure future clinical translation of biodegradable metals for bone fracture repair.展开更多
基金supported by the Grant for Development of New Faculty Staff,Ratchadaphiseksomphot Endowment Fund,Chula-longkorn University,Thailand(Grant No.:DNS64_047_33_003_1 to Patanachai K.Limpikirati)Grant for Development of New Scholar,Office of the Permanent Secretary,Ministry of Higher Ed-ucation,Science,Research and Innovation,Thailand(Grant No.:RGNS64_012 to Patanachai K.Limpikirati).
文摘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 compliance.Pharmaceutical 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 appropriately.Conformance 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 criteria.Quality 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 specifications.Acceptance criteria are set forth primarily based on efficacy and safety profiles,with an increasing attention noted for patient-centric specifications.Discussed 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 monographs.Outlooks are also explored on process analytical technologies and other orthogonal tools which are on-trend in biopharmaceutical characterization and quality control.
基金supported by the Special Fund of Scientific Research Base for Drug Regulation of NMPA-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(2021jgkx004).
文摘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 China.Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States.Results 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.
文摘Objective To sort out the focus areas of FDA’s scientific supervision and to achieve corresponding results,so as to provide some suggestions for the scientific research and innovation of drug supervision in China.Methods In-depth research was carried out in the fields of safety evaluation tools,clinical trial innovation,new methods of product quality evaluation,information science and so on.Results and Conclusion The research foundation of drug supervision related technology in China is weak,and a systematic supervision system has not been formed.Learning from the scientific experience of drug supervision in the United States,we can promote the development of the focus areas of drug supervision in China.Besides,we should improve the standard management ability while perfecting the regulations and standards system.Lastly,we should establish a system for government and industry-university-research to realize the full-cycle supervision of drugs.
文摘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 products.During 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 viruses.In 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 China.Further,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 supervision.Ultimately,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.
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Shenyang Pharmaceutical University Research Institute of Drug Regulatory Science(2020jgkx005).
文摘Objective To analyze the current situation of research and application of drug regulatory science in EU,and provide suggestions for policy-making of drug regulatory in China.Methods The policy guidelines issued by European Medicines Agency(EMA)and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe.Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science,and the construction of academic system and discourse system of regulatory science were improved,which played a role in promoting the progress of European drug regulatory science.It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible.Besides,the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs.
文摘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.
基金The authors thank the financial support from National Natural Science Foundation of China(51973018)National Natural Science Foundation of China(51773018)Beijing Municipal Science and Technology Commission Projects(No.Z191100002019017).
文摘Regulatory science for medical devices aims to develop new tools,standards and approaches to assess the safety,effectiveness,quality and performance of medical devices.In the field of biomaterials,hernia mesh is a class of implants that have been successfully translated to clinical applications.With 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 markets.The 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 reported.Then the research prospect of regulatory science for hernia mesh was discussed.New 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 assessed.By 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 decision-making.This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants.It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.
基金financially supported by the Sichuan Science and Technology Program(No.2021YFS0020)the Natural Science Foundation of China(No.32001002)supported by the second batch(“3.1 Investigating technologies of assessing the safety and effectiveness of nano-medical device products”,“5.3 Investigating innovative supervision and assessment technologies of tissue engineered medical device products”,“5.4 Research,development and translation of innovative biomaterials”and“5.5 Research on technical evaluation of recombinant collagens,cartilagerepair materials and antimicrobial orthopedic/dental materials”)of Chinese Drug Regulatory Science Action Plan of National Medical Products Administration。
文摘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 evaluation.The updated definition of biomaterials,and concepts of biomaterials-related medical products and so-called medical-grade and implantable materials are firstly introduced.Then 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 presented.Finally,the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are discussed.As 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.
文摘Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the“14th five-year plan”to deepen the reform of medical and health system.Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process,operation mode,practical significance and characteristics of the big data platform for FDA regulatory science,which would help China to establish a perfect big database.Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States.It is necessary to build data platforms in line with China’s national conditions through efforts in law,talents,standards,and other aspects.
文摘We presented a control strategy for tablet manufacturing processes based on continuous direct compression.The work was conducted by the experts of pharmaceutical companies,machine suppliers,academia,and regulatory authority in Japan.Among 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 manufacturing.The 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 feeder.Based on these ideas,the concept of process control using RTD was summarized.
基金supported by China’s Action Plan on Scientific Drug Administration(technical evaluation of drug-device combination products)National Natural Science Foundation of China(NSFC,No.32001002)+2 种基金National Key Research and Development Program of China(No.2017YFE0102600)Sichuan Major Science and Technology Project on Biotechnology and Medicine(No.2018SZDZX0018)Sichuan University Postdoctoral Interdisciplinary Innovation Startup Found.
文摘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.The product research and development,clinical translation as well as regulatory evaluation of combination products are complex and challenging.This review firstly introduced the origin,definition and designation of combination products.Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented.Preclinical and clinical evaluation of combination products was discussed.Lastly,the research prospect of regulatory science for combination products was described.New 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 products.Taken 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.
基金supported by the first batch of Chinese Drug Regulatory Science Action Plan(Regulatory science research on new materi-als for medical device)This work was also supported by the sec-ond batch(“5.5 Research on technical evaluation of recombinant collagens,cartilage repair materials and antimicrobial orthope-dic/dental materials”)of Chinese Drug Regulatory Science Action Plan of NMPA.
文摘The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This 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 magnesium.Then,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory aspects.Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.
文摘Biodegradable metals are promising candidates for bone defect repair.With an evidence-based approach,this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal models for bone defect repair to explore their potential clinical translation.Animal studies on bone defect repair with biodegradable metals in comparison with other traditional biomaterials were reviewed.Data was carefully collected after identification of population,intervention,comparison,outcome,and study design(PICOS),and following the inclusion criteria of biodegradable metals in animal studies.30 publications on pure Mg,Mg alloys,pure Zn and Zn alloys were finally included after extraction from a collected database of 2543 publications.A qualitative systematic review and a quantitative meta-analysis were performed.Given the heterogeneity in animal model,anatomical site and critical size defect(CSD),biodegradable metals exhibited mixed effects on bone defect repair and degradation in animal studies in comparison with traditional non-degradable metals,biodegradable polymers,bioceramics,and autogenous bone grafts.The results indicated that there were limitations in the experimental design of the included studies,and quality of the evidence presented by the studies was very low.To enhance clinical translation of biodegradable metals,evidence-based research with data validity is needed.Future studies should adopt standardized experimental protocols in investigating the effects of biodegradable metals on bone defect repair with animal models.
基金We acknowledge the financial support from the National Natural Science Foundation of China(81873184).
文摘Biodegradable metals hold promises for bone fracture repair.Their clinical translation requires pre-clinical evaluations including animal studies,which demonstrate the safety and performance of such materials prior to clinical trials.This evidence-based study investigates and analyzes the performance of bone fractures repair as well as degr adation properties of biodegradable metals in animal models.Data were carefully collected after identification of population,interventions,com-parisons,outcomes and study design,as well as inclusion criteria combining biodegradable metals and animal study.Twelve publications on pure Mg,Mg alloys and Zn alloys were finally included and reviewed after extraction from a collected database of 2122 publications.Compared to controls of traditional non-degradable metals or resorbable polymers,biodegradable metals showed mixed or contradictory outcomes of fracture repair and degradation in animal models.Although quantita-tive meta-analysis cannot be conducted because of the data heterogeneity,this systematic review revealed that the quality of evidence for biodegradable metals to repair bone fractures in animal models is'very low'.Recommendations to standardize the animal studies of biodegradable metals were proposed.Evidence based biomaterials research could help to both identify reliable scientific evidence and ensure future clinical translation of biodegradable metals for bone fracture repair.
