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The biopharmaceutical industry in China: history and future perspectives
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《医学前沿(英文)》 2012年 第6卷 第2期 页码 101-111 doi: 10.1007/s11684-012-0191-9
Biopharmaceuticals reflect the rapid progress achieved in modern biomedical research. This area has also become one of the main criteria for assessing the development level of biotechnology for a particular country. Although it has been only three decades since the first biopharmaceutical, recombinant human insulin, was licensed by the US Food and Drug Administration, the biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive sector in the biomedical field. Since the licensing of recombinant human interferon α1b in 1989, the biopharmaceutical industry in China has gone through initial developments and gradually entered a period of rapid growth. This paper provides an overview of the status and development trends of biopharmaceuticals in China, and compares them with those observed in developed countries.
关键词: biopharmaceuticals antibodies market trends diseases China national regulatory agency
The regulatory sciences for stem cell-based medicinal products
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《医学前沿(英文)》 2014年 第8卷 第2期 页码 190-200 doi: 10.1007/s11684-014-0323-5
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
Zero E-waste: Regulatory impediments and blockchain imperatives
Mengjun Chen, Oladele A. Ogunseitan
《环境科学与工程前沿(英文)》 2021年 第15卷 第6期 doi: 10.1007/s11783-021-1402-x
关键词: Blockchain E-waste Regulatory Policy Copyright Laws Repair-Reuse-Remanufacture Toxicity
Disinfection byproducts in drinking water and regulatory compliance: A critical review
Xiaomao WANG,Yuqin MAO,Shun TANG,Hongwei YANG,Yuefeng F. XIE
《环境科学与工程前沿(英文)》 2015年 第9卷 第1期 页码 3-15 doi: 10.1007/s11783-014-0734-1
关键词: Disinfection byproducts (DBPs) drinking water standards regulatory compliance alternative disinfection information collection rule (ICR) emerging DBPs
Liver cell therapies: cellular sources and grafting strategies
《医学前沿(英文)》 2023年 第17卷 第3期 页码 432-457 doi: 10.1007/s11684-023-1002-1
关键词: liver regeneration hepatocytes cholangiocytes stem cells organoids regulatory mechanisms transplantation/grafting strategies
《农业科学与工程前沿(英文)》 2021年 第8卷 第2期
Metabolites, especially secondary metabolites, are very important in the adaption of tea plants and the quality of tea products. Here, we focus on the seasonal variation in metabolites of fresh tea shoots and their regulatory mechanism at the transcriptional level. The metabolic profiles of fresh tea shoots of 10 tea accessions collected in spring, summer, and autumn were analyzed using ultra-performance liquid chromatography coupled with quadrupole-obitrap mass spectrometry. We focused on the metabolites and key genes in the phenylpropanoid/flavonoid pathway integrated with transcriptome analysis. Multivariate statistical analysis indicates that metabolites were distinctly different with seasonal alternation. Flavonoids, amino acids, organic acids and alkaloids were the predominant metabolites. Levels of most key genes and downstream compounds in the flavonoid pathway were lowest in spring but the catechin quality index was highest in spring. The regulatory pathway was explored by constructing a metabolite correlation network and a weighted gene co-expression network.
Life-cycle cost analysis of optimal timing of pavement preservation
Zilong WANG,Hao WANG
《结构与土木工程前沿(英文)》 2017年 第11卷 第1期 页码 17-26 doi: 10.1007/s11709-016-0369-3
关键词: pavement preservation life-cycle cost analysis agency cost vehicle operation cost
Green Construction of National Speed Skating Oval
《工程管理前沿(英文)》 2022年 第9卷 第1期 页码 170-176 doi: 10.1007/s42524-021-0177-x
关键词: super large-span cable net structure CO2 Transcritical Direct-cooling Ice Making System dynamic high-precision construction measurement green construction National Speed Skating Oval
调节性T细胞及其在抗肿瘤免疫疗法中的临床应用 Review
解丰, 梁瑞, 李丹, 李斌
《工程(英文)》 2019年 第5卷 第1期 页码 132-139 doi: 10.1016/j.eng.2018.12.002
癌症是可能危及生命的疾病,特点在于肿瘤细胞在宿主身上无限增殖。最近,因其具有预防肿瘤进展和转移的巨大潜力,免疫疗法受到越来越多研究者的关注。调节性T 细胞(Treg)是对维持宿主免疫稳态起重要作用的抑制性CD4+ T 细胞的一个亚群。调节性T 细胞缺陷可引起严重的自身免疫、过敏和自身炎症等疾病。调节性T 细胞通常富集在肿瘤微环境中,而大量免疫抑制调节性T细胞往往表明预后较差。因此,人们对调节性T 细胞的功能及其在抗肿瘤免疫疗法中的临床应用再次产生了兴趣。越来越多的策略关注调节性T 细胞的消耗,这在抗肿瘤免疫方面似乎有效。预计调节性T 细胞靶向策略与其他疗法(如嵌合抗原受体T 细胞疗法或免疫检查点阻断)联用将为提高抗肿瘤疗效带来重大机遇。
Chen-Kai JIANG, De-Jiang NI, Ming-Zhe YAO, Jian-Qiang MA, Liang CHEN
《农业科学与工程前沿(英文)》 页码 215-230 doi: 10.15302/J-FASE-2021382
关键词: harvest season metabolites tea shoots transcriptomics untargeted metabolomics
药品监管科学推动中国新冠病毒疫苗研发概述 Review
黄志明, 付志浩, 王军志
《工程(英文)》 2022年 第10卷 第3期 页码 127-132 doi: 10.1016/j.eng.2022.01.001
监管科学是一门综合应用自然科学、社会科学和人文科学,开发新工具、新标准和新方法,以评估受监管产品的安全性、有效性、质量和性能的学科。监管科学研究的根本目的是为行政决策提供技术支撑。在甲型H1N1流感、严重急性呼吸综合征(SARS)和中东呼吸综合征(MERS)等传染病大流行期间,监管科学研究有力支持了抗病毒药物和疫苗的研发。特别在新型冠状病毒(简称新冠病毒)肺炎(COVID-19)疫情大流行期间,药品监管科学支持下的疫苗研发在疫情防控中发挥了重要作用。本文总结了中国疫苗产业、新冠病毒疫苗研发以及疫苗监管科学发展的总体概况。此外,本文重点从国家规划、法律法规、技术指南、质量控制和疫苗上市后监管等方面,回顾和分析了监管科学研究为推动中国新冠病毒疫苗研发所发挥的重要作用。本文为当前大流行阶段以及后疫情时代的疫苗研发策略制定提供参考,并为将来如何更好地应对新发和再发传染病提供借鉴和指导。
《医学前沿(英文)》 2023年 第17卷 第1期 页码 85-92 doi: 10.1007/s11684-021-0917-7
Regulatory issues for genetically modified animals
Perry Bradbury HACKETT
《农业科学与工程前沿(英文)》 2020年 第7卷 第2期 页码 188-203 doi: 10.15302/J-FASE-2019307
Precision genetics and breeding have the potential to meet the agricultural needs and goals of the world in the 21st century. These needs include increasing the efficiency of production of animals and improving their products with minimal impact on the environment. The USA is the major innovator in genomic science and the acknowledged leader in formulating policies to regulate genetic applications in medicine and agriculture. However, governments worldwide have been exceedingly reluctant to support the introduction of genetically modified (GM) animals into agriculture. Regulatory policies have stagnated due to legal guidelines that could not anticipate the needs and solutions that are evident today. This must change if we are to maintain planetary integrity. I propose a new, market-based regulatory model for GM livestock that has both a strong scientific foundation and has worked for 10000 years. The model is similar to that for information technology in which specific algorithms drive computer and cell phone applications. Genome engineers write genetic algorithms that drive the traits in biological organisms. Accordingly, GM products should be viewed in terms of their use and public benefit rather than by limitations to the genetic programing coming from a few highly vocal groups. Genetic algorithms (Genapps) of the 21st century will include not only introduction of synthetic genes, but also complete natural and synthetic biochemical pathways to produce agricultural products that are maximally efficient, healthy to humans and animals, and sustainable in an era of changing climates while avoiding environmental degradation.
刘辉亮
《中国工程科学》 2016年 第18卷 第5期 页码 100-108 doi: 10.15302/J-SSCAE-2016.05.014
2016年是美国国家公园管理局成立100周年。在过去的100年里,美国国家公园系统已成为重要的国家资源,在刺激经济发展和提高公众生活质量方面起着重要的作用,对门户城镇经济发展尤为如此。本文简要回顾了美国国家公园系统,包括它的历史、使命、规划重点和方法,并着重探讨了门户城镇和国家公园之间相互依托、相互合作、共同发展的关系,以及随着近年来国家公园游客、门户城镇访客和居民数量的日益增长,它们所面临的问题和挑战。笔者以落基山国家公园和它的主要门户城镇——埃斯蒂斯公园小镇 (the Town of Estes Park) 作为案例,探讨其成功的经验与存在的具体问题,并就有关中国国家公园系统的设立、国家公园和其门户城镇的关系及规划重点等提出建议,仅供“秦巴山区绿色循环发展”研究项目参考。
标题 作者 时间 类型 操作
Zero E-waste: Regulatory impediments and blockchain imperatives
Mengjun Chen, Oladele A. Ogunseitan
期刊论文
Disinfection byproducts in drinking water and regulatory compliance: A critical review
Xiaomao WANG,Yuqin MAO,Shun TANG,Hongwei YANG,Yuefeng F. XIE
期刊论文
METABOLIC AND TRANSCRIPTOME ANALYSIS REVEALS METABOLITE VARIATION AND FLAVONOID REGULATORY NETWORKS IN
期刊论文
METABOLIC AND TRANSCRIPTOME ANALYSIS REVEALS METABOLITE VARIATION AND FLAVONOID REGULATORY NETWORKS IN
Chen-Kai JIANG, De-Jiang NI, Ming-Zhe YAO, Jian-Qiang MA, Liang CHEN
期刊论文
Achievements of the national malaria control and elimination program in the People’s Republic of China
期刊论文