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101.
Richard M. Nixon Anthony O'Hagan Jeremy Oakley Jason Madan John W. Stevens Nick Bansback Alan Brennan 《Pharmaceutical statistics》2009,8(4):371-389
The development of a new drug is a major undertaking and it is important to consider carefully the key decisions in the development process. Decisions are made in the presence of uncertainty and outcomes such as the probability of successful drug registration depend on the clinical development programmme. The Rheumatoid Arthritis Drug Development Model was developed to support key decisions for drugs in development for the treatment of rheumatoid arthritis. It is configured to simulate Phase 2b and 3 trials based on the efficacy of new drugs at the end of Phase 2a, evidence about the efficacy of existing treatments, and expert opinion regarding key safety criteria. The model evaluates the performance of different development programmes with respect to the duration of disease of the target population, Phase 2b and 3 sample sizes, the dose(s) of the experimental treatment, the choice of comparator, the duration of the Phase 2b clinical trial, the primary efficacy outcome and decision criteria for successfully passing Phases 2b and 3. It uses Bayesian clinical trial simulation to calculate the probability of successful drug registration based on the uncertainty about parameters of interest, thereby providing a more realistic assessment of the likely outcomes of individual trials and sequences of trials for the purpose of decision making. In this case study, the results show that, depending on the trial design, the new treatment has assurances of successful drug registration in the range 0.044–0.142 for an ACR20 outcome and 0.057–0.213 for an ACR50 outcome. Copyright © 2009 John Wiley & Sons, Ltd. 相似文献
102.
Sequential case series analysis for pharmacovigilance 总被引:1,自引:0,他引:1
Mounia N. Hocine Patrick Musonda Nick J. Andrews C. Paddy Farrington 《Journal of the Royal Statistical Society. Series A, (Statistics in Society)》2009,172(1):213-236
Summary. The self-controlled case series method is used to evaluate drug safety, particularly the safety of paediatric vaccines with respect to rare adverse reactions. We propose a group sequential version of the method for prospective surveillance of drug safety. We focus on the surveillance of new vaccines. We develop methods that are based on the sequential probability ratio test applied at predetermined surveillance intervals, using both simple and composite alternative hypotheses. We investigate the properties of the methods analytically in a simple setting and by simulations in more realistic scenarios. The methods are applied to data on influenza vaccine and Bell's palsy, and to data on measles, mumps and rubella vaccine and bleeding disorders. 相似文献
103.
In the late 1980s and early 1990s, much attention was paid by British agricultural geographers to the restructuring of the farm sector under pressures of national, European and global change. The need to adopt a perspective capable of looking beyond the farm gate inspired the introduction of modified political economy approaches into agricultural research. One important cornerstone of the empirical application of this thesis was the concept of the ‘farm adjustment strategy’. This attempted to map out the responses, especially those of survival, made by farm family businesses to rapidly changing agrarian conditions. Subsequently, the farm adjustment strategy became remarkable for its popularity as a way to organise research into agricultural change in developed market economies. Following a retreat in the 1990s, there has been something of a recent revival in the use of the term ‘strategy’ relating to agricultural adjustment. Revisiting this concept is therefore timely. Using empirical evidence from studies of farming change in the Welsh Marches, this paper examines two issues. First, it makes a critical re-examination of the concept to resolve differences with interpretation linked to theoretical perspectives so that future misuse can be minimised. Second, an attempt is made to assess the relevance of defined elements of farm adjustment strategies to analyses of farm business change. In so doing, there is an attempt to recover our knowledge of agrarian restructuring and to help situate newly encultured investigations into the likely survival of family labour-based forms of production. 相似文献
104.
The economic implications of increasing life expectancy are important concerns for governments in developed countries. The aims of this study were as follows: (i) to forecast mortality for 14 developed countries from 2010 to 2050, using the Poisson Common Factor Model; (ii) to project the effects of the forecast mortality patterns on support ratios; and (iii) to calculate labour force participation increases which could offset these effects. The forecast gains in life expectancy correlate negatively with current fertility. Pre-2050 support ratios are projected to fall most in Japan and east-central and southern Europe, and least in Sweden and Australia. A post-2050 recovery is projected for most east-central and southern European countries. The increases in labour force participation needed to counterbalance the effects of mortality improvement are greatest for Japan, Poland, and the Czech Republic, and least for the USA, Canada, Netherlands, and Sweden. The policy implications are discussed. 相似文献
105.
The spaces and ethics of organic food 总被引:2,自引:0,他引:2
Initial assessments of the potential for organic food systems have offered an optimistic interpretation of the progressive political and ethical characteristics involved. This positive gloss has prompted a stream of critique emphasising the need to explore the ambiguities and disconnections inherent therein. In this paper, we consider the case of Riverford Organic Vegetables,1 arguably the largest supplier of organic vegetables in the UK, and suggest that existing debates assume too much about the “goods” and “rights” of organic food and leave important questions about the spaces and ethics of organic food. We argue that, in the case of Riverford, the space of organic food production and distribution is neither the small, local, counter-cultural farm nor the large, transnational, corporate firm. Rather, simultaneously, the spaces of organic food production and distribution are the national network, the regional distribution system and the local farm. In addition, in the case of Riverford, the ethics of organic food exhibit few grand designs (of environmental sustainability, for example). Rather, the ethics of organic food are best characterised as: ordinary, since they relate to concerns about taste, value for money, care within the family and so on; diverse, since multiple practices steer the production and distribution of organic food; and graspable, in that both vegetables and box have material and symbolic presence for consumers. 相似文献
106.
107.
In this article we reflect on the complexity and the contested nature of the roles of multi‐disciplinary teams working with children. This is an increasingly important issue in the current UK child welfare policy environment. The article uses the theories of Etienne Wenger to understand data gathered from five multi‐disciplinary teams working with children. We explore key issues relating to location; information sharing; models of understanding; and professional identities. We hope to demonstrate that the teams addressed tensions creatively through their engagement with diversity while at the same time developing common team values. We argue that effective strategies for making multi‐disciplinary teams work will combine inter‐agency issues with internal team‐specific aspects. Copyright © 2007 John Wiley & Sons, Ltd. 相似文献
108.
109.
In prior writings, we have explored alternative means of justifying claims in evaluation practice. After a brief review of these previous investigations, we provide an analysis employing Toulmin's (1958) jurisprudence metaphor in the assessment of evaluative arguments. Applications and implications for evaluation practice are discussed. 相似文献
110.
This article reviews developments in children's services since 1997 and considers their effect on children in need by examining government statistics, recent additions to the evidence‐base, and data from two studies conducted by the authors. It shows that there has been extensive service development, mainly beyond the Department of Health, and considerable effort to improve assessment and administrative data. The limits to what can be demonstrably achieved by children's services, particularly in a short period, are acknowledged, and it is argued that the approach of providing predominantly low level interventions to large groups may need re‐thinking if significant and lasting changes to children's development are to be secured. Copyright © 2003 John Wiley & Sons, Ltd. 相似文献