Effect of batch age on potency and dissolution of levothyroxine sodium tablets: impact of BP and USP monograph differences on dissolution results

Controversies surround levothyroxine sodium as a drug and product, and are reflected in compendia (USP vs BP) differences in levothyroxine sodium tablets specifications concerning potency limit and dissolution test conditions, and in lack of consensus on several issues such as whether the drug BCS class I or III. We have recently published a clinical study in patients comparing the efficacy of multisource 100?mcg levothyroxine sodium tablets (three sources, two brands, a total of five batches). Clinical efficacy and dissolution rate data varied among the tablet batches studied and indicated that brand/source interchangeability could not be claimed. The efficacy parameters showed good correlation with dissolution data generated under BP 2014, but not under USP 2014 dissolution test conditions. In the present study, we decided to expand the number of tablet batches studied in vitro to a total of 12, to report potency and content uniformity data missing in the clinical study, and to further examine the discrepancy in dissolution results based on the medium used. The wide range of batch age in the studied samples allowed investigating the effect of batch age on in-vitro tablet performance parameters. Generated potency values indicated the prevalence of super-potent tablet batches. The dissolution data reflected the effect of compendia monograph differences in dissolution medium. The results also indicated an inverse relationship between tablet potency and batch age and, between dissolution and batch age. The possible effect of potency results on the generated dissolution data was discussed. Statistical significance of correlations examined was assessed by linear and non-linear regression analysis. Statistical significance was evident for the relation between batch age and BP 2014 dissolution data, compared to USP 2014 dissolution results.     

英国文官制度及其对我国公务员制度的启示

现代文官制度在世界政治文明上占有重要地位,英国是文官制度建立最早也比较成熟的国家。文官制度建立至今已有一百四十多年的历史,但是它所确立的制度并没有过时。虽然,中英两国公务员制度在理论和实际运作上存在着很大的差距,但在经济全球化的大形势下,借鉴英国的文官制度对推动我国公务员制度的改革与完善具有一定意义上的促进作用。     

美国高校服务学习的发展历程及其启示

服务学习作为美国高校普遍运用的一种教育方式或是服务形式,将学校课程与社区服务相结合,以实现提高学生学习能力与效果、加强学生公民责任感、促进社会发展等目标。美国高校服务学习的发展历程可以划分为重技能培养的实践教育、项目化管理的志愿服务、组织建设推动下的服务学习和法律规范下的服务学习四个阶段,每个阶段都有其具体特征。梳理美国高校服务学习的发展历程,为我国高校服务学习的起航提供一些参考和启示。     

一种解调时统信号新方法的探讨

在原理分析的基础上,提出了用8098CPU作主控芯片,把IRIG-B码的模拟信号经A/D转换后,用数字逻辑来解调IRIG-B(AC)码的新方法。经理论分析和实践检验,证明它简单实用、同步精度高、具有较强的抗干扰能力。     

Housing affordability,tenure and mental health in Australia and the United Kingdom: a comparative panel analysis

This paper contributes insights into the role of tenure in modifying the relationship between housing affordability and health, using a cross-national comparison of similar post-industrial nations—Australia and the United Kingdom—with different tenure structures. The paper utilises longitudinal data from the Household, Income and Labour Dynamics in Australia Survey and British Household Panel Survey to examine change in the mental health of individuals associated with housing becoming unaffordable and considers modification by tenure. We present evidence that the role of tenure in the relationship between housing and health is context dependent and should not be unthinkingly generalised across nations. These findings suggest that the UK housing context offers a greater level of protection to tenants living in unaffordable housing when compared with Australia, and this finds expression in the mental health of the two populations. We conclude that Australian governments could improve the mental health of their economically vulnerable populations through more supportive housing policies.     

美国国家公园的法律基础

始于黄石公署的国家公园的建立，是美国人在历史上的创举。美国国会的立法、决议以及相关政策的制定伴随着美国国家公园发展的全过程。这一系列法律、法规和相关政策始终强调这样一个理念：必须把国家公园的资源和价值完整地留给了子孙后代，让他们共享这些资源和价值。     

美国战后新城镇开发建设及其启示

美国是世界上城市化水平最高的市场经济国家，其城市化快速发展过程中的问题累积到二战后导致城市危机，美国政府通过城市更新、示范城市，推进郊区化等措施都无法缓和危机。1960年代中期的城市骚乱促使联邦政府加快了城市改造步伐，新城镇开发建设是美国城市改造的一种尝试，其失败的经验教训对我国城市建设和发展有很大启示。     

世界大都市圈的人口发展及特征分析

以美国和日本为重点 ,分析了世界大都市圈的人口发展及其规模、结构、分布等特征。探讨了美国大都市圈发展的基本态势、新特点及其产生的矛盾 ,并特别就纽约大都市区的人口发展提出 :(1 )人口总量的变动受到移民的强烈影响 ;(2 )在人口郊区化的大潮下 ,中心城市仍有所复兴 ;(3)由一个特大城市组合一批中小城市形成庞大的组团式城市群。同时探讨了日本大都市圈发展的基本态势和特点 ,并针对东京大都市圈的人口发展提出 :(1 )总人口增长显著超过全国平均增长率 ;(2 )人口迅速进入少子高龄化 ,但其程度明显低于日本其他地区 ;(3)人口大量由中心城市向近、远郊区的中小城镇扩散 ,形成世界最大的通勤圈 ;(4)人口的就业结构大幅度向第三产业倾斜     

Perspective from the United States: Tensions between “Getting It Done” and “Getting It Right”

For over 2 decades, and in response to complaints that arbitration was too expensive and too time consuming, the American construction bar has been energetic and innovative in developing a broad array of dispute resolution tools for resolving construction disputes. These “tools” have included “partnering,” mandatory negotiations, interim decision making by design professionals, mediation, standing neutrals and dispute resolution boards, minitrials, early neutral evaluation, and expert determinations, all developed as alternatives to arbitration and litigation. More recently, in 2006, a voluntary “fast track” process for resolving construction disputes within 100?days has been proffered by the CPR Institute for Conflict Prevention and Resolution. Yet, there are certain dynamics or “tensions” inherent within, and associated with, all construction disputes that continue to resist efforts to speed up dispute resolution processes; these tensions must be reconciled or taken into account before any fast track or “adjudication”-type process will be generally accepted in the United States construction industry. Thus, for now and in the foreseeable future, there will continue to be a smorgasbord of dispute resolution processes for resolution of construction disputes. This is a good thing, because parties to construction disputes come with a great variety of appetites and needs. The focus of attention should be, not so much on development of the ideal or best dispute resolution tool, but having a willingness to select the “best tool for the job,” after the nature of the dispute is known.     

Evolution of Statutory Adjudication as a Form of Dispute Resolution in the U.K. Construction Industry

This paper reports on the rapid growth in the use of this form of dispute resolution and its apparent decline. It considers how this novel form of dispute resolution has changed in nature from its original limited role of providing a speedy and inexpensive process of resolving disputes so that cash could flow in the industry and be of help primarily to those in the lower reaches of the subcontracting chain into a highly developed legal process which has increasingly been utilized for large and contractually complex disputes. Statutory adjudication is still used extensively in the U.K. construction industry as the method of choice to resolve disputes, many of which would previously have gone to court or to arbitration. Data for this study were provided by the Adjudication Reporting Center at Glasgow Caledonian University.