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.     

Performance of coefficient of variation estimators in ranked set sampling

In this paper, we propose and evaluate the performance of different parametric and nonparametric estimators for the population coefficient of variation considering Ranked Set Sampling (RSS) under normal distribution. The performance of the proposed estimators was assessed based on the bias and relative efficiency provided by a Monte Carlo simulation study. An application in anthropometric measurements data from a human population is also presented. The results showed that the proposed estimators via RSS present an expressively lower mean squared error when compared to the usual estimator, obtained via Simple Random Sampling. Also, it was verified the superiority of the maximum likelihood estimator, given the necessary assumptions of normality and perfect ranking are met.     

From Thatcherism to Blairism

From 1979 to 1997 the Conservative governments of Margaret Thatcher and John Major tried to refashion British society along the managerial lines suggested by the New Right. Since 1997, New Labour has attempted to consolidate those reforms by offering a kind of ‘compassionate Thatcherism’. The article offers an overview and a critical assessment of the social and political reforms that characterize this neo-liberal consensus. The main thesis is that at the core of those reforms there is a double policy of administrative decentralization cum political centralization the goal of which is to shift the costs of social change upon middle and lower level managers while freeing the government from accountability. Against Thatcher’s libertarian rhetoric, it is argued that this policy has augmented the role of the state in society. In opposition to Blair’s Third Way discourse, it is maintained that this policy has increased inequalities, entrenched social, economic and geographical divides and re-enforced the deep-seated tendencies of the British political system towards centralization.     

桑原骘藏关于安氏家族和布哈拉关系的误解

在详细叙述桑原骘藏关于安氏家族来自布哈拉的论文之后 ,富安敦认为 ,根据《河西节度副大使安公碑铭并序》、《元和姓纂》以及其他一些史料 ,武威安氏家族在汉代由安息入华 ,这个家族的来源与布哈拉没有任何关系     

The labour division of Italian couples after a birth: assessing the effect of unobserved heterogeneity

The results of previous studies on the effect of childbearing on both parents’ paid and unpaid work suffer from the difficulty related to the specification of latent variables that influence the relationship between reproductive behaviour of the couple and working activity. The aim of this study is to estimate the effect of transition to parenthood on the partners’ division of labour by accounting for latent variables, such as the bargaining process between partners and endogenous fertility decisions. In particular, this is the first time that our specific estimation strategy has been applied to determine the impact of childbearing on the division of household labour between partners taking into account the reverse causality effect between labour and fertility decisions. We use longitudinal data on married or cohabiting Italian couples provided by the Italian panel survey of the Generation and Gender Program. Our results are consistent with previous studies, and show that the birth of a child affects a woman’s unpaid labour strongly and positively and her paid labour negatively, while men’s work is mostly unaffected. Moreover, when partners hold traditional attitudes regarding gender roles and the family, the female partner is even more strongly affected by childbearing in terms of total amount of labour (paid plus unpaid). However, our sensitivity analysis shows that these results appear only when our correction strategy for the misspecification of latent variables is applied.

     

NONPARAMETRIC STATISTICS IN MULTICRITERIA ANALYSIS

The paper deals with a method of hierarchization of alternatives in a multicriteria environment by means of statistical nonparametric procedures. For each criterion, alternatives are disposed on an ordinal scale. After that a procedure similar to ANOVA is activated on the data. The differences relating to the average ranks of each action are used to build the hierarchical algorithm. The concept of outranking, in a probabilistic meaning, is reached in this way. Thereafter, we arrive at the concept of dominance using pairwise comparisons. A case study is presented which implements the methodological suggestion.     

Measuring Tourist Satisfaction Through a Dual Approach: The 4Q Methodology

Tourist satisfaction is one of the key factors in determining the success of a tourist destination, since it affects behavioural intentions, such as the willingness to revisit and recommend the destination. Therefore, much research has addressed the measuring of tourist satisfaction, either eliciting positive or negative evaluations of a holiday or destination. The spread between expected positive and negative characteristics can trigger a tourist experience. And the gap between expectations and perceptions will produce a feeling of satisfaction or dissatisfaction (Expectancy-Disconfirmation Paradigm, EDP). Under these conditions, this paper adopts a dual approach, considering tourist satisfaction and dissatisfaction as two distinct constructs; it also proposes a practical methodology, termed 4Q, for measuring these constructs in the field of tourism research. Lastly, two distinct composite indicators relating to Tourist Satisfaction (TS) and Tourist Dissatisfaction (TD) are proposed, for comparing the performance of tourist destinations over space and time, and addressing marketing strategies regarding different tourist segments.