Blinded sample size re‐estimation in crossover bioequivalence trials

In drug development, bioequivalence studies are used to indirectly demonstrate clinical equivalence of a test formulation and a reference formulation of a specific drug by establishing their equivalence in bioavailability. These studies are typically run as crossover studies. In the planning phase of such trials, investigators and sponsors are often faced with a high variability in the coefficients of variation of the typical pharmacokinetic endpoints such as the area under the concentration curve or the maximum plasma concentration. Adaptive designs have recently been considered to deal with this uncertainty by adjusting the sample size based on the accumulating data. Because regulators generally favor sample size re‐estimation procedures that maintain the blinding of the treatment allocations throughout the trial, we propose in this paper a blinded sample size re‐estimation strategy and investigate its error rates. We show that the procedure, although blinded, can lead to some inflation of the type I error rate. In the context of an example, we demonstrate how this inflation of the significance level can be adjusted for to achieve control of the type I error rate at a pre‐specified level. Furthermore, some refinements of the re‐estimation procedure are proposed to improve the power properties, in particular in scenarios with small sample sizes. Copyright © 2014 John Wiley & Sons, Ltd.     

工笔重彩课程教学改革的几点设想

从分析当前工笔重彩课程教学的弊端出发,对工笔重彩课程教学的教学模式、教学核心、课程衔接等三个方面做出对比分析,提出对工笔重彩课程改革的建议和设想。     

中国现代宗教学术研究一百年的回顾与展望

本文对近百年来中国现代宗教学术研究的进程作了简要的历史回顾,对中国宗教学的特点作了概要的分析研究,并在总结经验与教训的基础上提出,以一种学术开放精神来对待宗教学的各种理论与方法,是推动中国宗教学进一步发展的重要条件。     

苏南模式及其再创造

主要阐述了苏南模式的历史由来 ,分析其曾经辉煌与后来相对落后的原因 ,提出在新的时代背景与外部环境下 ,应该通过不断的改造、创新 ,创造出新的苏南模式。     

胡适与晚清文学改良思潮

晚清文学改良思潮对胡适　产生了极大的影响，这不仅体现在胡适承袭了梁启超等人的以文艺作为新民手段上，还表现　在他们在诗歌革命的宏观问题上，也有大致相似的看法。当然，胡适也有所创新。这首先表　现在具体到如何进行诗界革命时，胡适与梁启超的不同意见。其次　，胡适发起文学革命时　更多考虑了文学界的不令人满意的现状和文学自身的特性。胡适的独特贡献还在于将文学　革命与白话文运动紧密结合起来，认为要达到教育民众的目的，必须创造出能为大多数民众　所接受的白话文学。     

De l'indocilité au travail d'une fraction des jeunesses populaires.: Les apprentis et la culture ouvrière

Research on apprentices in two big public enterprises leads us to put in perspective the prevailing theses based on arguments about the rejection of the working-class heritage and the disappearance of forms of resistance among young people with working-class origins. Focusing on contexts of apprenticeship it sheds light on how apprentices cope with requirements related to situations at the workplace. Apprenticeship — an uncertain, contingent, unsteady position in the world of work — does not motivate these young people to identify collectively with other wage-earners; nor does it facilitate the acquisition of class consciousness. In this sense, it relates to a process of social rather than occupational integration. However apprentices reinvent traditional and/or new practices of resistance (opposition, evasion or pretending) that enable them to skirt around or even modify work-related requirements. Entry into the world of work, as well as the resulting pleasure or disenchantment, can be marked by feelings other than “disaffection” with labor, a sense of submission or individualism, or a fascination or identification with the middle classes.     

建立独立董事制度规范公司法人治理结构

随着经济全球化步伐的日益加快,加快建立独立董事制度,规范中国公司法人治理结构毋庸置疑.通过借鉴英美法系国家建立独立董事制度与规范公司法人治理结构的经验,本文就加快建立独立董事制度,规范中国公司法人治理结构的重大意义及应解决的若干问题略作探讨.     

再就业与中小企业发展

我国中小企业在发展过程中 ,面临产业结构、产品结构、行业结构的不合理 ,技术水平落后 ,缺乏金融支持 ,人才匮乏等问题 ,导致竞争实力下降 ,发展后劲不足。通过中小企业采取各种扶持政策 ,是保证其健康发展的重要保证 ,也是培育新的就业增长点的客观要求。对策包括 :强化战略规划和政策研究 ,建立企业指导管理机构 ,构筑金融支持体系 ,创建社会化人才服务体系 ,完善法律保障体系 ,搞好结构调整 ,深化内部管理等等。     

Arbeitsteilung,Berufsorientierung und Partnerschaftsstabilität – Ehen und nichteheliche Lebensgemeinschaften im Vergleich*

The central finding of this paper is that the link between the division of labour and the risk of separation differs depending on the type of relationship. Marriages tend to be destabilised by the wife’s participation in the labour force and stabilised by the traditional division of labour. Empirical evidence of this is manifest in a positive effect of the wife’s income and a negative effect of the husband’s relative income on the likelihood of separation. In contrast to this, unmarried long-term relationships are stabilised by egalitarian division of labour. This is evident from the absence of negative effects of an employment of the female cohabiter on stability of relationship. Furthermore, in unmarried cohabitations the relative income of the man increases the risk of a separation. In addition to the income ratio, homogamous attitudes have explanatory value. Cohabitations are stable when both partners are career-oriented. This finding points to an egalitarian gender-role-orientation among unmarried men. It also implies that an egalitarian orientation has an impact on the living arrangement which needs to be accepted by both partners – for instance when family planning and timing of marriage are concerned.     

康德视野中对人权与对物权的区分

康德在其名著《法的形而上学导论》中,以其意志哲学为出发点,对“对人权”与“对物权”的区分进行了独到的分析。他区分了物权的形式定义与真正定义,指出了物权的绝对性;他将对人权还原为一种意志关系,将对人权的客体理解为人的行为,还将交付理解为一种合同;他提出了特有的“物权性的对人权”这一概念,并分析、论证了“买卖破租赁”的命题,从而指出了物权的优先性。康德的这些观点对于后世民法教义学与立法产生了重大影响。