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51.
Alan Phillips Alan Ebbutt Lesley France David Morgan Mick Ireson Lesley Struthers Guenter Heimann 《Pharmaceutical statistics》2003,2(4):241-251
The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd. 相似文献
52.
Jason P. Fine David V. Glidden Kristine E. Lee 《Journal of the Royal Statistical Society. Series B, Statistical methodology》2003,65(1):317-329
Summary. We propose a simple estimation procedure for a proportional hazards frailty regression model for clustered survival data in which the dependence is generated by a positive stable distribution. Inferences for the frailty parameter can be obtained by using output from Cox regression analyses. The computational burden is substantially less than that of the other approaches to estimation. The large sample behaviour of the estimator is studied and simulations show that the approximations are appropriate for use with realistic sample sizes. The methods are motivated by studies of familial associations in the natural history of diseases. Their practical utility is illustrated with sib pair data from Beaver Dam, Wisconsin. 相似文献
53.
This study examined the emergence of affect specificity in infancy. In this study, infants received verbal and facial signals of 2 different, negatively valenced emotions (fear and sadness) as well as neutral affect via a television monitor to determine if they could make qualitative distinctions among emotions of the same valence. Twenty 12‐ to 14‐month‐olds and 20 16‐ to 18‐month‐olds were examined. Results suggested that younger infants showed no evidence of referential specificity, as they responded similarly to both the target and distracter toys, and showed no evidence of affect specificity, showing no difference in play between affect conditions. Older infants, in contrast, showed evidence both of referential and affect specificity. With respect to affect specificity, 16‐ to 18‐month‐olds touched the target toy less in the fear condition than in the sad condition and showed a larger proportion of negative facial expressions in the sad condition versus the fear condition. These findings suggest a developmental emergence after 15 months of age for affect specificity in relating emotional messages to objects. 相似文献
54.
To ascertain the viability of a project, undertake resource allocation, take part in bidding processes, and other related decisions, modern project management requires forecasting techniques for cost, duration, and performance of a project, not only under normal circumstances, but also under external events that might abruptly change the status quo. We provide a Bayesian framework that provides a global forecast of a project's performance. We aim at predicting the probabilities and impacts of a set of potential scenarios caused by combinations of disruptive events, and using this information to deal with project management issues. To introduce the methodology, we focus on a project's cost, but the ideas equally apply to project duration or performance forecasting. We illustrate our approach with an example based on a real case study involving estimation of the uncertainty in project cost while bidding for a contract. 相似文献
55.
David Smith 《Children & Society》2003,17(3):226-235
The paper discusses the reasons for the large amount of critical commentary that New Labour's reforms of the youth justice system have attracted. It explores the extent to which there is something ‘new’ about these reforms, suggesting that there are important differences when New Labour's approach is compared with its predecessor's. It then discusses the main lines of critical commentary on the reforms, concluding that much of it is over‐abstract and insufficiently empirically informed. The paper concludes with some ambiguous evidence on what the impact of the reforms has actually been. Copyright © 2003 John Wiley & Sons, Ltd. 相似文献
56.
The authors explored predictions of general job satisfaction at early and middle adulthood and uncovered several findings about developmental processes associated with job satisfaction. Tests of life‐span career theory propositions revealed that neither choice‐job congruence nor gender added significantly to predictions of job satisfaction at 2 career stages. Earlier occupational choice and current job added to predictions of midcareer (modal age 43 years) job satisfaction, especially for men. The predictability of job satisfaction is apparently influenced by the career stage when satisfaction is appraised. 相似文献
57.
In this note, we consider the problem of estimating regression coefficients when there are missing observations of some explanatory variables. Following Dagenais (1973), Gourieroux and Monfort (1981), and Conniffe (1983a, 1983b), we assume auxiliary relationships exist among explanatory varibles. Several estimatprs and their interrelationships are discussed. We begin with the model of Gourieroux and
Monfort (1981) 相似文献
Monfort (1981) 相似文献
58.
59.
Modeling for Risk Assessment of Neurotoxic Effects 总被引:2,自引:0,他引:2
The regulation of noncancer toxicants, including neurotoxicants, has usually been based upon a reference dose (allowable daily intake). A reference dose is obtained by dividing a no-observed-effect level by uncertainty (safety) factors to account for intraspecies and interspecies sensitivities to a chemical. It is assumed that the risk at the reference dose is negligible, but no attempt generally is made to estimate the risk at the reference dose. A procedure is outlined that provides estimates of risk as a function of dose. The first step is to establish a mathematical relationship between a biological effect and the dose of a chemical. Knowledge of biological mechanisms and/or pharmacokinetics can assist in the choice of plausible mathematical models. The mathematical model provides estimates of average responses as a function of dose. Secondly, estimates of risk require selection of a distribution of individual responses about the average response given by the mathematical model. In the case of a normal or lognormal distribution, only an estimate of the standard deviation is needed. The third step is to define an adverse level for a response so that the probability (risk) of exceeding that level can be estimated as a function of dose. Because a firm response level often cannot be established at which adverse biological effects occur, it may be necessary to at least establish an abnormal response level that only a small proportion of individuals would exceed in an unexposed group. That is, if a normal range of responses can be established, then the probability (risk) of abnormal responses can be estimated. In order to illustrate this process, measures of the neurotransmitter serotonin and its metabolite 5-hydroxyindoleacetic acid in specific areas of the brain of rats and monkeys are analyzed after exposure to the neurotoxicant methylene-dioxymethamphetamine. These risk estimates are compared with risk estimates from the quantal approach in which animals are classified as either abnormal or not depending upon abnormal serotonin levels. 相似文献
60.
This report summarizes the proceedings of a conference on quantitative methods for assessing the risks of developmental toxicants. The conference was planned by a subcommittee of the National Research Council's Committee on Risk Assessment Methodology 4 in conjunction with staff from several federal agencies, including the U.S. Environmental Protection Agency, U.S. Food and Drug Administration, U.S. Consumer Products Safety Commission, and Health and Welfare Canada. Issues discussed at the workshop included computerized techniques for hazard identification, use of human and animal data for defining risks in a clinical setting, relationships between end points in developmental toxicity testing, reference dose calculations for developmental toxicology, analysis of quantitative dose-response data, mechanisms of developmental toxicity, physiologically based pharmacokinetic models, and structure-activity relationships. Although a formal consensus was not sought, many participants favored the evolution of quantitative techniques for developmental toxicology risk assessment, including the replacement of lowest observed adverse effect levels (LOAELs) and no observed adverse effect levels (NOAELs) with the benchmark dose methodology. 相似文献