A comparative study of confidence intervals to assess biosimilarity from analytical data

Assessment of analytical similarity of tier 1 quality attributes is based on a set of hypotheses that tests the mean difference of reference and test products against a margin adjusted for standard deviation of the reference product. Thus, proper assessment of the biosimilarity hypothesis requires statistical tests that account for the uncertainty associated with the estimations of the mean differences and the standard deviation of the reference product. Recently, a linear reformulation of the biosimilarity hypothesis has been proposed, which facilitates development and implementation of statistical tests. These statistical tests account for the uncertainty in the estimation process of all the unknown parameters. In this paper, we survey methods for constructing confidence intervals for testing the linearized reformulation of the biosimilarity hypothesis and also compare the performance of the methods. We discuss test procedures using confidence intervals to make possible comparison among recently developed methods as well as other previously developed methods that have not been applied for demonstrating analytical similarity. A computer simulation study was conducted to compare the performance of the methods based on the ability to maintain the test size and power, as well as computational complexity. We demonstrate the methods using two example applications. At the end, we make recommendations concerning the use of the methods.     

Urban ecosystem Services in Latin America: mismatch between global concepts and regional realities?

Urban Ecosystems - Latin America and the Caribbean (LAC) is one of the most urbanized and biologically diverse regions in the world but is often characterized by weak environmental governance and...     

Value-added distribution to stakeholder of Spanish listed companies: a corporate governance perspective

Journal of Management and Governance - Following a stakeholder corporate governance perspective, we examine whether the characteristics of boards of directors (board size, separation of Chairman...     

Gender-related factors in family business succession: a systematic literature review

Review of Managerial Science - Succession is one of the most discussed topics in family business research. However, despite the changing professional and family roles of women and the growing...     

Life Domain Satisfaction: A Portugal–France Comparison

The study was aimed at replicating on a Portuguese sample the seven-factor model of life appraisal (physical autonomy, love life, family life, social life, occupational life, finances, and leisure life) that was suggested by Salvatore and Munoz Sastre Social Indicators Research 53:229–255 (2001). A sample of 1,111 Portuguese participants, aged 17–85, was presented with the Appraisal of Life Questionnaire. The “domain” model of life appraisal satisfactorily accounted for the data gathered on the Portuguese sample. Regarding finances and occupational life, Portuguese scores were lower than French scores. Regarding the occupational score and the leisure score, a clear linear decrease as a function of age was evidenced in the Portuguese sample. Finally, regarding the family score and the financial score, a non-linear relationship with age was found. An increase was observed from young adult age to adult age, and a decrease was observed from adult age to older age. A strong decrease in the physical autonomy scores among Portuguese females was also observed.     

Town Centre Management: Outlook from Portugal

In the last two decades, the Portuguese Government has responded to the decline of centres of commerce. In this paper, we analyse the three different experiences of town centre management (TCM) schemes developed in Portugal since the turn of the millennium. The first two stages were developed using public sector initiatives and their impacts were limited. The third stage is still under way and is composed of private projects created by local business owners. Taking Lisbon as a case study for this third stage we conclude that these projects have become a pro-active means of intervention in Portuguese town centres.     

New lower bounds for the second variable Zagreb index

The aim of this paper is to obtain new sharp inequalities for a large family of topological indices, including the second variable Zagreb index \(M_2^{\alpha }\), and to characterize the set of extremal graphs with respect to them. Our main results provide lower bounds on this family of topological indices involving just the minimum and the maximum degree of the graph. These inequalities are new even for the Randi?, the second Zagreb and the modified Zagreb indices.     

Initiative in work teams: adaptation and validation of the Personal Initiative at Group Level Scale / Iniciativa en los equipos de trabajo: adaptación y validación de la Escala de Iniciativa Personal a nivel Grupal

In this study, we conceptualize personal initiative as a collective construct and adapt and validate a scale to evaluate it with a sample of 308 Spanish participants belonging to 91 work teams. Personal initiative at group level is a behavioural syndrome in which the team shows an approach to work that is self-initiated, proactive, persistent, capable of modifying the atmosphere and pro organization. As a predictive variable, we analysed the climate for initiative as well as personal initiative at group level. The resulting variables that were analysed referred to organization and team performance, with the team productivity and innovation as the criteria, analysing radical innovation. The scale has suitable psychometric properties. The results show that there is a relationship between the two predictive variables. Furthermore, personal initiative at group level is related to team productivity, while the climate for initiative is related to innovation.     

‘What Was I Thinking?!’ Rhetorical Questions as a Technique to Identify and Explore Impasses in Therapy

Rhetorical questions emerging spontaneously in consultations can be used as a tool for developing self‐reflexivity and exploring the therapeutic alliance in the process of therapy with couples and families. This paper presents a technique based on the enunciation of rhetorical questions, which can point to an impasse in the process of therapy and contain a key to its resolution. The technique focuses on the distinctive feature of rhetorical questions as convening a paradoxical injunction: a question not intended as a question, while uttered as such. The technique in four steps is illustrated by examples from therapy, supervision, consultation, and self‐supervision. Its focus is the interlink between the therapeutic relationship and the process of therapy and it is informed by a second‐order cybernetics approach, dialogical practice, and the systemic literature on emotion. The technique can help develop curiosity in working with families, lead to unforeseen developments, and touch on prejudices not made explicit in previous therapeutic encounters. Whether we are acting as supervisors, therapists, or clients, the creation of a ‘secure enough’ context for rhetorical questions becomes critical to allow freeform exploration.