Recent changes in FDA's good laboratory practice regulations

In the Federal Register of December 22, 1978, the Food and Drug Administration (FDA) published regulations which described Good Laboratory Practice for safety tests conducted on regulated products (Anonymous, 1978). The regulations, popularly known as GLPs, have become universally recognized as the basic criteria for the conduct of a valid safety test and for assuring the quality and integrity of the collected data. Along with the publication of the GLPs, FDA instituted a vigorous program of inspection of toxicology laboratories to determine the degree of adherence to the regulations. In 1984, based on inspectional findings which revealed that a large majority of toxicology laboratories were adhering to the GLPs, FDA published a proposal intended to reduce the burden of compliance with the regulations (Anonymous, 1984). The proposal outlined major changes in the provisions on quality assurance, protocol preparation, test and control article characterization, and retention of specimens and samples. The final order based on the proposal was published in the federal register of September 4, 1987 (Anonymous). The purpose of this communication is to describe the procedures used by FDA to develop the final order, to discuss certain major issues that arose during its development, and to answer several questions that have arisen subsequently.     

区域性学业水平测试质量分析——小学数学学业水平检测试卷与课程标准一致性的视角

区域性学业水平测试是地方教育行政部门监测教育质量的重要方法。因此,分析区域性学业水平测试质量就显得十分重要。为此,借鉴韦伯一致性分析模式,对某地区小学数学学业水平检测试卷的质量进行了尝试探究,即从学习领域和年级两个方面分析了区域性小学数学学业水平测试与课程标准的一致性水平状况及特征。同时,还从数与代数、空间与图形、统计与概率、实践与综合应用等学习领域和知识种类、知识深度、知识广度和知识分布平衡性等"一致性维度"进行了归因分析。     

Chemical and Radiation Environmental Risk Management: Differences, Commonalities, and Challenges

Driven by differing statutory mandates and programmatic separation of regulatory responsibilities between federal, state, and tribal agencies, distinct chemical and radiation risk management strategies have evolved. In the field this separation poses real challenges since many of the major environmental risk management decisions we face today require the evaluation of both types of risks. Over the last decade, federal, state, and tribal agencies have continued to discuss their different approaches and explore areas where their activities could be harmonized. The current framework for managing public exposures to chemical carcinogens has been referred to as a "bottom up approach." Risk between 10(-4) and 10(-6) is established as an upper bound goal. In contrast, a "top down" approach that sets an upper bound dose limit and couples with site specific As Low As Reasonably Achievable Principle (ALARA), is in place to manage individual exposure to radiation. While radiation risk are typically managed on a cumulative basis, exposure to chemicals is generally managed on a chemical-by-chemical, medium-by-medium basis. There are also differences in the nature and size of sites where chemical and radiation contamination is found. Such differences result in divergent management concerns. In spite of these differences, there are several common and practical concerns among radiation and chemical risk managers. They include 1) the issue of cost for site redevelopment and long-term stewardship, 2) public acceptance and involvement, and 3) the need for flexible risk management framework to address the first two issues. This article attempts to synthesize key differences, opportunities for harmonization, and challenges ahead.     

试论我国当前的官德建设

提高政府官员的道德水平是我国经济社会发展的重要保证,也是实现"以德治国"方略的必然要求。当前应尽快建立和完善以"全心全意为人民服务"为基本原则的官德体系,加强官德建设,有效防范政府官员的腐败,提高行政效能。     

Inequality and welfare evaluation of heterogeneous income distributions

This paper establishes the principles that should govern the welfare and inequality analysis of heterogeneous income distributions. Two basic criteria – the equity preference condition and the compensation principle – are shown to be fundamentally incompatible. The paper favours the latter, thereby vindicating the traditional method of dealing with heterogeneous samples. However, inequality and welfare comparisons will usually be well defined only if equivalent incomes are obtained using constant scale factors; and researchers will need to distinguish clearly between inequality of nominal incomes and inequality of living standards. Furthermore, household observations must always be weighted according to family size.     

我看"红色经典"

“红色经典”是“17年文学”特定的“历史情境”的必然产物 ,其“史诗”性的创作追求一方面成就了“经典” ,另一方面也带来了其缺失 ;自“红色经典”诞生起 ,其随政治波涛起伏荣辱的历史命运更是当代文学史上的代表性现象。文章认为对经典的批评要以一定的文学理想境界作为每一位批评家的“果核”和“底子” ,从而在具体的“历史情境”下分析其文学意蕴 ,确立其文学史意义 ;轻易作出武断结论的批评态度是不可取的。同时文章也提出 ,当代文学要在新世纪开拓出一片新的天空 ,如何正确对待文学维度与政治维度关系仍是一个必须跨过的堤岸。     

Methods Used with a High Ability Group

Teaching for social justice in a standards-driven social studies classroom can be challenging. However, the authors believe that there does not have to be a choice between meeting standards versus meeting the needs of students. Through semistructured interviews with four current social studies practitioners, the authors found similarities in the language the teachers used to describe the role of standards in their classrooms, teachers' perceptions of context as being important to the tension between teaching for social justice and teaching to standards, and the ways that perception impacted how they negotiated that tension. The authors offer social studies teachers an alternate conceptual frame for viewing social justice instruction in terms of methods rather than content.     

浅论我国行政赔偿的范围

随着我国社会的发展出现的新情况以及《国家赔偿法》本身的原因,行政赔偿的不足表现在:行政赔偿归责原则单一;抽象行政行为被排除在侵权损害赔偿之外;精神损害赔偿的缺失;不作为和怠慢行政赔偿;赔偿标准不够完善等一系列问题。究其原因主要是:传统官本位思想的制约以及当今执政理念的宣传教化;国家财政负担问题;相关法学理论的不成熟;国家行政机关的强势地位等。结合行政赔偿范围的缺陷和原因,给出相关建议。     

高校公用计算机实验室的管理与维护

高校公用计算机实验室数量多、单间实验室面积大、机器台数多、使用的软件涵盖了几乎各个学科,使用者程度不同,除了承担教学任务外,还承担各类不同的计算机统考任务,如何有效地管理和维护好这些计算机是一件非常重要的事情。以琼州学院电子信息工程实验中心公用计算机实验室的管理和改革为实例,论述了高等学校公用计算机实验室的管理与维护,从实践本身对如何提高软硬件的运行效率,保证实验教学正常、高效地开展进行探讨.     

优化中国企业对欧盟市场的出口进入方式

中国对欧盟的巨额贸易顺差令欧盟感到不满，欧盟对华反倾销措施、种类繁杂的技术性贸易壁垒是中国企业面临的主要问题，另外，被较多采用的间接出口方式不利于中国企业对欧盟出口的可持续发展。要想优化对欧盟市场的出口进入方式，中国企业要深入了解欧盟市场对内自由、对外统一的实质，熟悉欧盟共同商业政策，提供符合欧盟标准的商品，积极应对、合理规避欧盟反倾销措施，采用间接出口与直接出口相结合并且更多采用直接出口的方法。