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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

摘要:

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

null

《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

摘要:

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    

工程采购的代理成本

陈守科,韦灼彬

《中国工程科学》 2005年 第7卷 第11期   页码 66-71

摘要:

以非对称信息博弈及委托-代理理论为理论背景,分析了工程采购代理成本的产生、组成及内涵关系,并对最优激励合同的设计、最优监督策略及其成本做了分析说明。

关键词: 工程采购     代理成本     非对称信息博弈     委托-代理理论    

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

摘要: Abstract • Copyrights on electronic products are impediments in promoting circular economy. • Manufacturers antagonize refurbishment and remanufacturing to maximize profit. • International harmonization of copyright laws will aid repair and remanufacture. • Blockchain–digital immutable ledgers–can promote trust among stakeholders. The concept of zero waste is an ideal situation that will require different solutions for different categories of waste. Electronic waste (E-waste), the fastest growing category of solid hazardous waste presents various unique challenges. Electronic product repair, reuse and remanufacture (3re) are crucial for effective source reduction of E-waste and the integration of the electronics industry into a circular or zero-waste economy framework. Increasingly, 3re implementation is restricted by regulatory difficulties, particularly the invocation of copyright laws. Here, we use the examples of electronic printer cartridges and restored compact discs (CDs) to identify the challenges and to explore solutions for managing the risks associated with E-waste through circular economy and the opportunities presented by innovative Blockchain solutions. A set of international consensuses on judicial definitions, such as 3re, refurbish fake/counterfeit product and copyright exhaustion, are proposed to accelerate source reduction in E-waste management toward the goal of zero waste.

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

摘要: Disinfection by-products (DBPs) are regulated in drinking water in a number of countries. This critical review focuses on the issues associated with DBP regulatory compliance, including methods for DBP analysis, occurrence levels, the regulation comparison among various countries, DBP compliance strategies, and emerging DBPs. The regulation comparison between China and the United States (US) indicated that the DBP regulations in China are more stringent based on the number of regulated compounds and maximum levels. The comparison assessment using the Information Collection Rule (ICR) database indicated that the compliance rate of 500 large US water plants under the China regulations is much lower than that under the US regulations (e.g. 62.2% versus 89.6% for total trihalomethanes). Precursor removal and alternative disinfectants are common practices for DBP regulatory compliance. DBP removal after formation, including air stripping for trihalomethane removal and biodegradation for haloacetic acid removal, have gained more acceptance in DBP control. Formation of emerging DBPs, including iodinated DBPs and nitrogenous DBPs, is one of unintended consequences of precursor removal and alternative disinfection. At much lower levels than carbonaceous DBPs, however, emerging DBPs have posed higher health risks.

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

摘要: The liver has a complex cellular composition and a remarkable regenerative capacity. The primary cell types in the liver are two parenchymal cell populations, hepatocytes and cholangiocytes, that perform most of the functions of the liver and that are helped through interactions with non-parenchymal cell types comprising stellate cells, endothelia and various hemopoietic cell populations. The regulation of the cells in the liver is mediated by an insoluble complex of proteins and carbohydrates, the extracellular matrix, working synergistically with soluble paracrine and systemic signals. In recent years, with the rapid development of genetic sequencing technologies, research on the liver’s cellular composition and its regulatory mechanisms during various conditions has been extensively explored. Meanwhile breakthroughs in strategies for cell transplantation are enabling a future in which there can be a rescue of patients with end-stage liver diseases, offering potential solutions to the chronic shortage of livers and alternatives to liver transplantation. This review will focus on the cellular mechanisms of liver homeostasis and how to select ideal sources of cells to be transplanted to achieve liver regeneration and repair. Recent advances are summarized for promoting the treatment of end-stage liver diseases by forms of cell transplantation that now include grafting strategies.

关键词: liver regeneration     hepatocytes     cholangiocytes     stem cells     organoids     regulatory mechanisms     transplantation/grafting strategies    

METABOLIC AND TRANSCRIPTOME ANALYSIS REVEALS METABOLITE VARIATION AND FLAVONOID REGULATORY NETWORKS IN

《农业科学与工程前沿(英文)》 2021年 第8卷 第2期

摘要:

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

摘要: Optimal application of pavement preservation or preventive maintenance is critical for highway agencies to allocate the limited budget for different treatments. This study developed an integrated life-cycle cost analysis (LCCA) model to quantify the impact of pavement preservation on agency cost and vehicle operation cost (VOC) and analyzed the optimal timing of preservation treatments. The international roughness index (IRI) data were extracted from the long-term pavement performance (LTPP) program specific pavement studies 3 (SPS-3) to determine the long-term effectiveness of preservation treatments on IRI deterioration. The traffic loading and the initial IRI value significantly affects life extension and the benefit of agency cost caused by pavement preservation. The benefit in VOC is one to two orders greater in magnitude as compared to the benefit in agency cost. The optimal timing calculated based on VOC is always earlier than the optimal timing calculated based on agency cost. There are considerable differences among the optimal timing of three preservation treatments.

关键词: pavement preservation     life-cycle cost analysis     agency cost     vehicle operation cost    

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

摘要:

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。

关键词: 调节性T细胞     癌症     免疫疗法    

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

《农业科学与工程前沿(英文)》   页码 215-230 doi: 10.15302/J-FASE-2021382

摘要: 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.

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

摘要:

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。

关键词: 监管科学     新冠病毒疫苗     疫苗产业    

Achievements of the national malaria control and elimination program in the People’s Republic of China

《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

摘要: In 2017, China achieved the target of zero indigenous malaria case for the first time, and has been certified as malaria free by World Health Organization in 2021. To further summarize the historical achievements and technical experiences of the elimination program, a project on the Roadmap Analysis and Verification for Malaria Elimination in China was carried out. Results of the project were compiled and published as the Atlas of Malaria Transmission in China (The Atlas). The Atlas using modern digital information technologies, has been supported by various data from 24 malaria endemic provinces of China since 1950, to assess the changes in malaria epidemic patterns from 1950 to 2019 at national and provincial levels. The Atlas is designed as two volumes, including a total of 1850 thematic maps and more than 130 charts, consisting of introductory maps, thematic maps of malaria epidemic and control at national and provincial levels. It objectively and directly shows the epidemic history, evolution process, and great achievements of the national malaria control and elimination program in China. The Atlas has important reference value for summing up historical experience in the national malaria elimination program of China, and malaria control and elimination in other endemic countries in the world.

关键词: malaria     transmission     control     elimination     China     atlas    

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

摘要:

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.

关键词: algorithms     editing     FDA     GMO     recombinant DNA     USDA    

美国国家公园与门户城镇的建设经验与启示

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

摘要:

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。

关键词: 美国国家公园管理局     门户城镇     落基山国家公园     埃斯蒂斯公园小镇    

标题 作者 时间 类型 操作

The biopharmaceutical industry in China: history and future perspectives

null

期刊论文

The regulatory sciences for stem cell-based medicinal products

null

期刊论文

工程采购的代理成本

陈守科,韦灼彬

期刊论文

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

Liver cell therapies: cellular sources and grafting strategies

期刊论文

METABOLIC AND TRANSCRIPTOME ANALYSIS REVEALS METABOLITE VARIATION AND FLAVONOID REGULATORY NETWORKS IN

期刊论文

Life-cycle cost analysis of optimal timing of pavement preservation

Zilong WANG,Hao WANG

期刊论文

Green Construction of National Speed Skating Oval

期刊论文

调节性T细胞及其在抗肿瘤免疫疗法中的临床应用

解丰, 梁瑞, 李丹, 李斌

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

药品监管科学推动中国新冠病毒疫苗研发概述

黄志明, 付志浩, 王军志

期刊论文

Achievements of the national malaria control and elimination program in the People’s Republic of China

期刊论文

Regulatory issues for genetically modified animals

Perry Bradbury HACKETT

期刊论文

美国国家公园与门户城镇的建设经验与启示

刘辉亮

期刊论文