Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

文学史的核心价值与古今演变

本文着重分析在过去的文学史研究中古代与现代相互隔绝的成因与弊病 ,提出从重新阐释中国文学的历史与传统入手 ,沟通古今文学 ,研究其演变的过程 ;提出文学史的核心价值是文学与人性发展的关系、文学在此发展过程中的作用 ,并主张以此核心价值为主线来研究古今文学之演变。     

Sample size re‐estimation incorporating prior information on a nuisance parameter

Prior information is often incorporated informally when planning a clinical trial. Here, we present an approach on how to incorporate prior information, such as data from historical clinical trials, into the nuisance parameter–based sample size re‐estimation in a design with an internal pilot study. We focus on trials with continuous endpoints in which the outcome variance is the nuisance parameter. For planning and analyzing the trial, frequentist methods are considered. Moreover, the external information on the variance is summarized by the Bayesian meta‐analytic‐predictive approach. To incorporate external information into the sample size re‐estimation, we propose to update the meta‐analytic‐predictive prior based on the results of the internal pilot study and to re‐estimate the sample size using an estimator from the posterior. By means of a simulation study, we compare the operating characteristics such as power and sample size distribution of the proposed procedure with the traditional sample size re‐estimation approach that uses the pooled variance estimator. The simulation study shows that, if no prior‐data conflict is present, incorporating external information into the sample size re‐estimation improves the operating characteristics compared to the traditional approach. In the case of a prior‐data conflict, that is, when the variance of the ongoing clinical trial is unequal to the prior location, the performance of the traditional sample size re‐estimation procedure is in general superior, even when the prior information is robustified. When considering to include prior information in sample size re‐estimation, the potential gains should be balanced against the risks.     

And I Still Love Them: On Touching Loss

In this article, the author performs a re‐membering practice that incorporates a relational materialist theory. It traces the disturbances that follow in the wake of three deaths in her family. Written in an autoethnographic voice, the article is a polyphonic composition of the narrative therapy approach of re‐membering entangled with the spacetimematter of silence, speaking, sitting, staying, presence, absence, loss of momentum, dreams, trees, books, cardiac pace‐makers, writing, breath, ashes, murmuring, suffering. Thus, the dispersed agencies of bodies, human and non‐human, reinvigorate a linguistic practice and the author's personal and professional life.     

A not so strange silence: Why qualitative researchers should respond critically to the qualitative data archive

A driving force behind the establishment of a qualitative data archive in the United Kingdom has been the oral historian, Paul Thompson. He has complained that there is a ‘strange silence’ among qualitative sociologists on re‐analysis, and that many have been reluctant to deposit data. The first part of the paper suggests that the common ethical and practical objections can be overcome in establishing an archive in Australia. However, there is a more serious underlying ideological objection: that archiving promotes and institutionalises a narrow empiricist version of qualitative research. The rest of the paper makes this case by examining teaching materials on a British website, by reviewing Thompson's arguments, and by considering some examples of re‐analysis by sociologists. It is argued that qualitative researchers should respond critically, but that it is possible to address and overcome these problems when developing an Australian archive.     

王韶《平戎策》中处理民族关系的原则及借鉴意义--兼补辑《全宋文》中的王韶文

王韶是北宋神宗朝开拓熙河而立下赫赫战功的大军事家、政治家.其<平戎策>提出了恩信招抚、汉法教化、平等相待、杂居互学、发展经济等处理民族关系的原则,在今天仍具有借鉴意义.另为<全宋文>补辑王韶文五篇.     

转型期我国职工下岗问题的社会学分析

企业职工大规模下岗是我国转型期特有的经济社会现象.从社会学视角看,下岗实质上是失业,必然产生多重社会效应.再就业工程作为政府动员社会资源解决下岗失业问题的应急措施,不可能长期搞下去,必须着眼于劳动力市场的发育和完善,寻找市场、政府和社会三方面的结合点,这是解决下岗失业问题的治本之策.     

行政改革中的价值重塑与制度重塑

新中国成立以来,中央政府进行了多次行政改革,然而都始终跳不出"精简--膨胀--再精简--再膨胀"的怪圈.不合理的行政价值取向和无效的制度安排从根本上制约着政府行政改革的进程,这亦是行政改革的难点所在.因此,只有进行行政价值重塑和制度重塑,政府行政改革才能真正取得实效.     

科学体与艺术体定中结构的语义比较

本文仅从科学体和艺术体定中结构的语义的限制和修饰、语义的同一与矛盾和重复、辞格的语义比较、繁复定语的排列顺序的语义比较四个方面进行语义的比较。科学体定中结构的定语多为限制性定语,艺术体定中结构的定语多为修饰性定语;科学体定中结构的定语和中心语之间的语义具有同一性,艺术体定中结构的定语和中心语之间的语义具有矛盾性和重复性;科学体定中结构中常见的只有比喻式辞格,艺术体定中结构中包含多种辞格;艺术体或科学体定中结构繁复定语排列时所遵循的规律不同。     

论对物权、对人权与向物权概念的缘起——兼论注释法学派及后注释法学派对债权物权区分论的贡献

注释法学派以及后注释法学派法学家们关于对人权与对物权的区分,构成了德国法上的债权物权区分说的重要渊源之一.注释法学家与后注释法学家使用了ius in re一词,后注释法学家还对之进行了详尽的论述;后注释法学家已经开始将ius in re与ius in personam相区分;再次,奥尔良法学派首先提出ius and rem概念,该概念对后世的债权物权区分说甚至民法学本身产生了重大影响.