A Quality Risk Management Model Approach for Cell Therapy Manufacturing

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell‐based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator‐introduced variations, and affected by heterogeneity of the processed organs/tissues and lot‐dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell‐based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo‐quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed.     

住宅特征价格分析——以广州为例

以广州二手交易的596个高层楼盘、3703个交易样本为研究基础，采用特征价格法测度了影响广州市住宅价格的主要因素，它们分别是与商业中心的距离、与山江公园的距离、与地铁的距离、噪音、户型间隔、装修档次、朝向、楼层、楼龄、阳台数量10项因素，并给出了影响因素的隐含价值。     

论辩诉交易的发展及其借鉴意义

源自美国的辩诉交易虽从其产生时起就伴生着诸多争议,但长期的司法实践表明辩诉交易不仅在英美法系国家,而且在大陆法系国家都得到了充分地运用,并在一定程度上呈普遍发展的趋势.本文深入剖析了产生这种趋势的原因,并论证了我国借鉴辩诉交易的必要性和可行性,提出了设立控辩协商制度的初步构想.     

A weighted polynomial regression method for local fitting of spatial data

Typically, parametric approaches to spatial problems require restrictive assumptions. On the other hand, in a wide variety of practical situations nonparametric bivariate smoothing techniques has been shown to be successfully employable for estimating small or large scale regularity factors, or even the signal content of spatial data taken as a whole.We propose a weighted local polynomial regression smoother suitable for fitting of spatial data. To account for spatial variability, we both insert a spatial contiguity index in the standard formulation, and construct a spatial-adaptive bandwidth selection rule. Our bandwidth selector depends on the Gearys local indicator of spatial association. As illustrative example, we provide a brief Monte Carlo study case on equally spaced data, the performances of our smoother and the standard polynomial regression procedure are compared.This note, though it is the result of a close collaboration, was specifically elaborated as follows: paragraphs 1 and 2 by T. Sclocco and the remainder by M. Di Marzio. The authors are grateful to the referees for constructive comments and suggestions.     

“三讲“教育是推动高校改革和发展的强大动力

"三讲"教育是内蒙古农业大学组建以来发展历程中承上启下的一个重要阶段,是促进学校深度融合的一次思想理论武装,是推动学校改革发展的强大动力.     

帝国之梦的幻灭历程——评析英国战后初期的外交政策

第二次世界大城改变了世界的格局,传统的以欧洲为中心的国际关系格局己被美苏两极格局所取代。战争所引起的新势态要求英国的外交政策做出适当的调整。但由于外交政策的连续性,英国政府在战后初期仍竭力维持自己"大英帝国"的地位,这就使得其在处理国际事务时常常感到力不从心。从"三环外交"方针、英国对欧政策和苏伊士危机这三个方面对英国战后初期的外交政策进行评析进而阐述英国帝国之梦的幻灭历程。     

Behavioural Addictions in Adolescents and Young Adults: Results from a Prevalence Study

Our study aims to assess the prevalence of behavioural addictions in an adolescent population, evaluating the effects of gender and age, and to assess the correlations among different behavioural addictions. 2853 high school students were assessed in order to evaluate the prevalence of behavioural addictions such as Pathological Gambling (PG), Compulsive Buying (CB), Exercise Addiction (EA), Internet Addiction (IA), and Work Addiction (WA), in a population of Italian adolescents. The South Oaks Gambling Screen-Revised Adolescent (SOGS-RA), the Compulsive Buying Scale (CBS), the Exercise Addiction Inventory (EAI), the Internet Addiction Test (IAT), and the Work Addiction Risk Test (WART), were compiled anonymously by the students. Overall prevalence was 7.0% for PG, 11.3% for CB, 1.2% for IA, 7.6% for WA, 8.5% for EA. PG and EA were more common among boys, while gender had no effect on the other conditions. CB was more common among younger (<18 years old) students. The scores of all of these scales were significantly correlated. The strong correlation among different addictive behaviours is in line with the hypothesis of a common psychopathological dimension underlying these phenomena. Further studies are needed to assess personality traits and other clinical disorders associated with these problems behaviours.     

On cumulative entropies

In analogy with the cumulative residual entropy recently proposed by Wang et al. [2003a. A new and robust information theoretic measure and its application to image alignment. In: Information Processing in Medical Imaging. Lecture Notes in Computer Science, vol. 2732, Springer, Heidelberg, pp. 388–400; 2003b. Cumulative residual entropy, a new measure of information and its application to image alignment. In: Proceedings on the Ninth IEEE International Conference on Computer Vision (ICCV’03), vol. 1, IEEE Computer Society Press, Silver Spring, MD, pp. 548–553], we introduce and study the cumulative entropy, which is a new measure of information alternative to the classical differential entropy. We show that the cumulative entropy of a random lifetime X can be expressed as the expectation of its mean inactivity time evaluated at X. Hence, our measure is particularly suitable to describe the information in problems related to ageing properties of reliability theory based on the past and on the inactivity times. Our results include various bounds to the cumulative entropy, its connection to the proportional reversed hazards model, and the study of its dynamic version that is shown to be increasing if the mean inactivity time is increasing. The empirical cumulative entropy is finally proposed to estimate the new information measure.     

借鉴国外成功经验 探究创建“人文廊坊”的途径及对策

现代化城市的建设越来越注重以人为本、尊重人文的发展理念。＂人文廊坊＂建设目标的提出符合时代潮流且意义深远。分析国外城市在人文建设方面的特点、总结其成功经验,能够在实现途径方面为创建＂人文廊坊＂提供有益参考。