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Perceval Sondag Lingmin Zeng Binbing Yu Harry Yang Steven Novick 《Pharmaceutical statistics》2020,19(3):230-242
Potency bioassays are used to measure biological activity. Consequently, potency is considered a critical quality attribute in manufacturing. Relative potency is measured by comparing the concentration‐response curves of a manufactured test batch with that of a reference standard. If the curve shapes are deemed similar, the test batch is said to exhibit constant relative potency with the reference standard, a critical requirement for calibrating the potency of the final drug product. Outliers in bioassay potency data may result in the false acceptance/rejection of a bad/good sample and, if accepted, may yield a biased relative potency estimate. To avoid these issues, the USP<1032> recommends the screening of bioassay data for outliers prior to performing a relative potency analysis. In a recently published work, the effects of one or more outliers, outlier size, and outlier type on similarity testing and estimation of relative potency were thoroughly examined, confirming the USP<1032> outlier guidance. As a follow‐up, several outlier detection methods, including those proposed by the USP<1010>, are evaluated and compared in this work through computer simulation. Two novel outlier detection methods are also proposed. The effects of outlier removal on similarity testing and estimation of relative potency were evaluated, resulting in recommendations for best practice. 相似文献
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Harry Shier 《Children & Society》2001,15(2):107-117
The United Nations Convention on the Rights of the Child has raised the profile of children's participation in the United Kingdom. Hart's ‘ladder of participation’ has been the most influential model in this field. This paper offers an alternative model, based on five levels of participation: 1. Children are listened to. 2. Children are supported in expressing their views. 3. Children's views are taken into account. 4. Children are involved in decision‐making processes. 5. Children share power and responsibility for decision‐making. In addition, three stages of commitment are identified at each level: ‘openings’, ‘opportunities’ and ‘obligations’. The model thus provides a logical sequence of 15 questions as a tool for planning for participation. Copyright © 2001 John Wiley & Sons, Ltd. 相似文献
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This article introduces a tool that serves as a guide for building an effective bridge between the personal and technical aspects of therapy in supervision. The instrument is based on a model of clinical supervision that emphasizes the purposeful utilization of self—in the moment, with both flaws and strengths—in the therapeutic relationship in combination with the technical interventions with clients. The article also offers some aid to promote a personal integration of the philosophy underlying this supervisory model into a therapist's clinical thinking and practice . 相似文献
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Robert Evans Harry Collins Martin Weinel Jennifer Lyttleton‐Smith Hannah O'Mahoney Willow Leonard‐Clarke 《The British journal of sociology》2019,70(4):1561-1581
The nature and role of social groups is a central tension in sociology. On the one hand, the idea of a group enables sociologists to locate and describe individuals in terms of characteristics that are shared with others. On the other, emphasizing the fluidity of categories such as gender or ethnicity undermines their legitimacy as ways of classifying people and, by extension, the legitimacy of categorization as a goal of sociological research. In this paper, we use a new research method known as the Imitation Game to defend the social group as a sociological concept. We show that, despite the diversity of practices that may be consistent with self‐identified membership of a group, there are also shared normative expectations – typically narrower in nature than the diversity displayed by individual group members – that shape the ways in which category membership can be discussed with, and performed to, others. Two claims follow from this. First, the Imitation Game provides a way of simultaneously revealing both the diversity and ‘groupishness’ of social groups. Second, that the social group, in the quasi‐Durkheimian sense of something that transcends the individual, remains an important concept for sociology. 相似文献