国际防伪领域的重大突破——网屏编码与ITC技术介绍

伴随着世界经济的蓬勃发展,侵犯知识产权,伪造名牌商品,伪造产地证明,伪造有价证券、货币等成为世界所有国家所面临的社会问题,在我国假烟,假酒,假的食品,已经成为严重危害人民身体健康,危害社会安全稳定的一个最重要的社会问题。国家各个机构纷纷制定严格监管的法规以及具体监管系统的筹划,但是对于这样的社会问题,要想彻底解决,必须要建立一个可以使大众互动的具有大众识别真伪,大众参与评定商品优劣的物联网平台。     

Anticounterfeit protection of pharmaceutical products with spatial mapping of X-ray-detectable barcodes and logos

Counterfeit pharmaceutical products are a global threat to public health, and they undermine the credibility and the financial success of the producers of genuine products. The escalating circulation of counterfeit drugs demands new anticounterfeit measures that permit rapid screening, are nondestructive, and cannot be circumvented easily. Herein we describe a micro-X-ray diffraction (μ-XRD) protocol for this purpose capable of reading barcodes and logos fabricated on various substrates using soft-lithography stamping of compounds that can be read by X-ray diffraction but are invisible to the naked eye or optical microscopy. This method is demonstrated with barcodes and logos of compounds, approved by the Food and Drug Administration, printed on flat substrates as well as commercial aspirin and ibuprofen tablets. The μ-XRD protocol is nondestructive, automated, and user-friendly and can be used to certify the authenticity of drug tablets by mapping hidden patterns printed under the tablet coating and on packages.     

FDA crackdown on illegal products

During 2003, the Food and Drug Administration took significant strides to address the growing threat of illegal drugs and false health claims related to dietary supplements. "Our major priority is to continue fostering the legitimate manufacture, sale and use of FDA-regulated products while maintaining a zero-tolerance approach to illegal practices," says John Taylor, the FDA's associate commissioner for regulatory affairs. "We're working to allocate resources in a way that maximizes our impact on public health."     

A case study of machinery maintenance protocols and procedures within the UK utilities sector

Failure to conduct periodic fixed-time-to (or scheduled) maintenance on off-highway plant and equipment represents a significant health and safety hazard and major litigation risk for utility contractors completing service excavation and reinstatement works on public highways. Mini-excavators are a ubiquitous mobile plant item used for such tasks and have recently been responsible for several major injuries and fatalities involving workers and members of the public in the United Kingdom (UK). The research utilises the method of triangulation to examine the maintenance practices of utility contractors in the UK. Findings from the research reveal that a combination of prevailing market forces and internal ‘company’ pressures have inadvertently removed knowledgeable and trained operators, site foremen and managerial supervisors from hands-on maintenance inspections. Rather, ‘virtual’ maintenance protocols and procedures are adopted by head office but rarely fully implemented on-site. The research concludes with pragmatic recommendations and direction for future research.     

An overview of protective action decision-making for a nuclear power plant emergency

Protection of the public in a nuclear power plant emergency requires decision-makers to balance the time requirements from two chains of events: the events associated with a radiological release and the events involved with the response to that release. The management of these events is distributed among personnel at the nuclear plant, in the local community, and in state and federal agencies. All of these parties must coordinate their response to the emergency to assure that timely and effective protective response can be made by the risk area population. This article describes the process by which protective action recommendations (PARs) are developed in nuclear power plant emergency exercises and provides recommendations from research on emergency response in other types of natural and technological hazards.     

假冒伪劣产品盛行的危害成因及整治对策

假冒产品是指使用不真实的厂名、厂址、商标、产品名称、产品标识等从而使客户、消费者误以为该产品就是被假冒的产品。伪劣产品是指质量低劣或者失去使用性能的产品。假冒伪劣从形式上看,主要是假冒名牌产品,假冒大厂产品,以劣充优,以假充真。假冒伪劣从类别上看,主要是家电、烟、酒、服装、鞋帽、保健品、药品、食品、化妆品等居多,囊括了消费者的衣食住行用,并且这些大多是涉及人身安全健康的产品,其潜在的问题令人堪忧。     

健康风险沟通中信息图形设计的易读性与可及性研究——以新冠疫情为例

目的 在持续的公共卫生危机期间,以信息图形提升公众对健康风险的认识是必要的手段之一。但信息图形涉及对数据、概念、流程等科学话语的视觉转译,公众可能会面临信息理解的易读性和可及性的问题。确认何种健康信息及其图形感知的设计可提升对风险概念的有效理解。方法 以新冠信息图形为例,基于风险传播、风险大小、风险接触和风险规避4个典型的风险沟通的类型,展开了一项联合社区用户、专家和设计师的焦点小组研究。结果 研究得到了5项设计建议,包括简化信息但不牺牲信息的丰富性,提供风险背景的上下文,数值比例的图形转换,感知-概念的图文整合,区分受众不同健康素养水平,谨慎处理信息的伦理问题。结论 健康风险信息紧急而复杂。信息设计可以提前介入,理解细分人群的信息行为、信息环境,快速响应沟通策略。研究得出的相关结论可对健康风险沟通实践提供参考,亦可拓展信息设计对健康传播跨学科研究的新范式。     

Counterfeit capacitors in the supply chain

Counterfeit electronic components have become a significant concern in the electronic parts supply chain. Original equipment manufacturers in particular are concerned about counterfeit components as there have been several recent reports of counterfeit parts entering the supply chain of the US military. This paper presents a case study of multilayer ceramic capacitors for use in a printed circuit assembly in an electronic system on a military aircraft. The capacitors failed during a high temperature screening test. Upon failure analysis it was revealed that the capacitors were not made to the correct specifications and were suspected to be counterfeit and not the authentic military grade capacitors manufactured by Kemet. Further investigation revealed that the suspect multilayered ceramic capacitors had entered into the electronics parts supply chain and were sold as authentic Kemet capacitors that met the higher military-specified requirements. The manufacturing and distribution of the counterfeit capacitors were traced to locations where, according to Kemet, its authentic capacitors are neither manufactured nor distributed.     

Curbing counterfeit drugs

In June 2006, the Food and Drug Administration's Counterfeit Drug Task Force released a new report on ways to curb the growing problem of counterfeit drugs. The report recommends measures that emphasize certain regulatory actions and the use of new technologies for safeguarding the integrity of the drug supply in the United States.     

Action-research-based optimisation model for health care behaviour change in rural India

In this research, we utilise a multi-method braided approach for a real-world health care intervention in rural India. We first use action research to conceptually underpin the role of self-help groups, disease profiles and appropriate interventions in health care behaviour change and improvement. Action research is then coupled with a non-linear integer-programming-based simulation to determine how health care resources need to be distributed over time, disease type and groups. The action research provides specific research questions and distributional forms needed for the optimisation analysis, while the non-linear integer-programming simulation provides specific recommendations on where and when to distribute resources. External validity of the study is ensured by the adoption of recommendations in the field as part of the action research. Findings from this research have important policy implications. For example, it identifies the value of continuous embedded interventions as opposed to periodic ones and the importance of flexibility in terms of which community groups and disease types to serve over time. This research also provides an important bridge between the operations research, health care in developing nations, organisational theory and humanitarian operations bodies of knowledge.     

Public information and education sections of the Report of the Presidential Commission on Drunk Driving: a critique and a discussion of research implications

This is a critique of the Report of the Presidential Commission on Drunk Driving, with special attention to those sections dealing with public information and education. Emphasis is given to the role of research in public action against drinking and driving. The question of deterrence vis á vis education and rehabilitation is examined. School-based programs, beginning in the early years, are viewed as promising preventive measures, along with public information programs that target high-risk groups and are combined with grass-root community support and intervention. Criteria are studied for formative evaluation of school-based programs, and recommendations are made for research to combat drunk driving in both school-based and public information programs.     

Effects of the Orphan Drug Act: an Industrial Perspective

The recommendations of the Interagency Task Force on “Significant Drugs of Limited Commercial Value” had a major role in the passage of the Orphan Drug Act of 1983. This act was designed to create incentives for the industry to develop orphan drugs, in order to make these drugs available to those who need them. This paper discusses the incentives built into the Act, reports on the results of a mail survey to 100 pharmaceutical manufacturers, and generates recommendations for increasing the effectiveness of the 1983 Orphan Drug Act. The majority of the respondents felt that the delays in orphan drug development reflect the lack of specific FDA guidelines and/or clinical data on safety and efficacy. Industry feels that a ten year marketing exclusivity and increased federal grants for clinical research would accelerate development and marketing of orphan drugs.     

Effects of the Orphan Drug Act: an Industrial Perspective

Abstract

The recommendations of the Interagency Task Force on “Significant Drugs of Limited Commercial Value” had a major role in the passage of the Orphan Drug Act of 1983. This act was designed to create incentives for the industry to develop orphan drugs, in order to make these drugs available to those who need them. This paper discusses the incentives built into the Act, reports on the results of a mail survey to 100 pharmaceutical manufacturers, and generates recommendations for increasing the effectiveness of the 1983 Orphan Drug Act. The majority of the respondents felt that the delays in orphan drug development reflect the lack of specific FDA guidelines and/or clinical data on safety and efficacy. Industry feels that a ten year marketing exclusivity and increased federal grants for clinical research would accelerate development and marketing of orphan drugs.     

Nanotechnological medical devices and nanopharmaceuticals: the European regulatory framework and research needs

The European regulatory framework is examined in relation to nanotechnology based medical devices and medicinal products. Medical applications of nanotechnology will have to comply with the requirement for a high level of public health, safety, consumer, and environmental protection. An evaluation of the possible health or environmental risks of nanoparticles must therefore be carried out and it is important to ensure that particle size and chemistry are taken into account when investigating possible adverse effects. Further research is needed on the toxicological and ecotoxicological properties of nanoparticles, their uptake in the body, accumulation in tissues and organs, transport characteristics, exposure and dose-response data, and their distribution and persistence in the environment. The existing regulations appear adequate to manage the risks of nanotechnology at its current stage of development but continuous review of the regulatory regime will be needed to determine whether it is sufficient to protect human health and the environment. Modification of the legislation may prove necessary as new scientific evidence emerges regarding the effects of nanoparticles on living organisms and in the ecosystems.     

Drugs related to motor vehicle crashes in northern European countries: a study of fatally injured drivers

The aim of this study was to find which drugs and drug combinations were most common in drivers who died, in particular, in single vehicle crashes where the responsibility for the crash would be referred to the driver killed. The study included all available blood samples from drivers, who died within 24 h of the accident, in the years 2001 and 2002 in the five Nordic countries (total population about 24 million inhabitants). The samples were analysed for more than 200 different drugs in addition to alcohol, using a similar analytical programme and cut-off limits in all countries. In three countries (Finland, Norway and Sweden) blood samples were available for more than 70% of the drivers, allowing representative prevalence data to be collected. 60% of the drivers in single vehicle crashes had alcohol and/or drug in their blood samples, compared with 30% of drivers killed in collisions with other vehicles. In single vehicle accidents, 66% of the drivers under 30 years of age had alcohol and/or drugs in their blood (alcohol only – 40%; drugs only – 12%; alcohol and drugs – 14%). The drugs found were mostly illicit drugs and psychoactive medicinal drugs with warning labels (in 57% and 58% respectively of the drivers under 30 with drugs present). Similar findings were obtained for drivers 30–49 years of age (63% with alcohol and/or drugs). In drivers aged 50 years and above, killed in single vehicle crashes (48% with alcohol and/or drugs) illicit drugs were found in only one case, and psychoactive medicinal drugs were detected less frequently than in younger age groups. In 75% of single vehicle crashes, the driver was under 50 years. Thus, the majority of accidents where the drivers must be considered responsible, occurred with drivers who had recently used alcohol, or drugs, alone or in combination. The drugs involved were often illicit and/or psychoactive drugs with warning labels. Therefore a large proportion of single vehicle accidents appear to be preventable, if more effective measures against driving after intake of alcohol and drugs can be implemented.     

Maturing,Technology-Based,Born-Global Companies: Surviving Through Mergers and Acquisitions

To date, there has been little research about the corporate growth of born-global companies and relatively little data exist about their maturation, survival as independent companies (or failure to do so) and their international strategies. The present paper is based on an empirical study of Israeli technology-based companies that were identified in the late 1990s as born global. We collected data about the continuing development of these firms for the decade spanning 2000–2009. Our findings show that maturing technology-based, born-global companies can increase their chances of survival by acquiring other firms. Although such acquisitions do not increase profits, they allow born-global firms to continue increasing their sales and to expand and upgrade their product line, which in turn increases their chances of remaining independent. The data also show that if the firms prefer to merge with another company, they are in a better position if they do not acquire any other firms beforehand. Finally, our data show that although the majority of born-global companies can continue operations if they survived the first decade, they are not highly successful on the measures of growth and shareholder wealth. One of the recommendations of this study is that for maturing, technology-based, born-global companies to remain successful, they must be more aggressive in their M&A strategy than they are at the moment.     

中性硼硅玻璃与药物相容性研究进展

目的 药品包装材料与药物相容性实验是评价药品包装材料安全性能与药品质量的重要研究项目,中性硼硅玻璃具有膨胀系数小、耐极冷极热性强、不易炸裂、化学稳定性好等特点,已成为注射剂包装的首选材质.探索中性硼硅玻璃与药物相容性的研究进展与发展趋势,为中性硼硅玻璃用于药品包装材料提供参考.方法 分别从玻璃成分中金属离子向药液中的迁移量、有害物质的浸出量、不同温度与酸碱条件下玻璃的脱片、玻璃对药物的吸附以及药物对玻璃表面的侵蚀程度等方面综述中性硼硅玻璃与药物相容性的研究进展,考察中性硼硅玻璃对于药品质量的影响.结论 中性硼硅玻璃与药物的相容性评价方法逐渐完善,为中性硼硅玻璃作为药用包装材料的研究提供参考.     

水难溶性药物的载体材料研究进展

水难溶性药物因其在水中溶解度小使得药物的临床应用受到限制.将水难溶性药物通过某些载体包裹,是对水难溶性药物进行增溶的一种行之有效的方法.综述了水难溶性药物载体材料的研究进展,并总结了各种载体材料的优缺点.针对普遍存在的增溶效果不理想的问题,指出了几种载体未来的发展方向.表面活性剂胶束因其自身的毒性而逐渐被其它载体材料取代.环糊精和聚合物胶束具有广阔的发展前景.尽管脂质体作为水难溶性药物载体存在不足之处,但其可用作水溶性药物的载体或者制备成主动靶向制剂(例如单克隆抗体导向的脂质体)、物理化学靶向制剂(例如磁靶向脂质体),仍具有巨大的研究价值和发展空间.     

Ethical issues related to professional exposure of pregnant women in the medical field: monitoring and limiting effective dose

The International Commission on Radiological Protection recommendations for occupational exposed pregnant women do not imply necessarily the complete avoidance of work with radiation or radioactive materials. Instead, a careful review of the exposure conditions, once the pregnancy is declared, as part of the exercise of the ICRP optimisation principle (based in a teleological ethics point of view) is suggested. The dose limitation (following a deontological ethics point of view) of the fetus/embryo is, however, not clearly well established as happens in the case of workers or members of the public. Also, the justification of practices (to continue to work or not with radiation or radioactive materials) is not clearly addressed in most national or international recommendations. An analysis of this justification (bearing in mind both teleological and deontological ethics) is examined in this work having in mind the best interest of the child-to-be as well as other existing social and economical factors.