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31.
Jones TC 《Science and engineering ethics》2005,11(4):575-587
The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the
innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under
the present process, the system requires restructuring.
The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit
assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of
drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and
social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging
studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory
requirement.
To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing
clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory
process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care.
The author is Adjunct Professor of Medicine, Weill Medical College of Cornell University, New York, New York, USA. 相似文献
32.
Acetylcholine plays an important role in regulating the processing of sensory stimuli, and understanding its specific cellular actions is critical to understanding how sensory cortex develops and functions in different behavioral states. Here we review recent work on the cellular effects of nicotinic receptor activation in auditory cortex and describe how these actions could affect systems-level auditory function. In particular, we describe a novel function of nicotinic acetylcholine receptors to regulate glutamate synapses containing N-methyl-D-aspartate receptors during early postnatal development. The transient regulation of developing glutamate synapses also defines a window of vulnerability during which exposure to exogenous nicotine disrupts synapse development. Thus, it appears that nicotinic regulation of glutamate synapses is a critical feature of auditory cortex development. 相似文献
33.
34.
Evaluating the Factor Structure of the MIDI Personality Scale Using Exploratory Structural Equation Modeling
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Mohsen Joshanloo 《The Japanese psychological research》2018,60(3):162-169
This study investigated the factor structure of the 26‐item Midlife Development Inventory (MIDI) Personality Scale in a sample of 2,720 Americans. It was found that whereas confirmatory factor analysis (CFA) did not provide an acceptable fit to the data, exploratory structural equation modeling (ESEM) provided an acceptable fit. The results of ESEM revealed that the a priori five‐factor structure of personality was generally consistent with the data, and all items had salient loadings on their target factors. ESEM also revealed that some of the items contributed significantly to more than one personality factor. The results are in line with previous research, and indicate that ESEM is more suitable than CFA for the study of personality traits. 相似文献
35.
Research on the division of cognitive labor has found that adults and children as young as age 5 are able to find appropriate experts for different causal systems. However, little work has explored how children and adults decide when to seek out expert knowledge in the first place. We propose that children and adults rely (in part) on “mechanism metadata,” information about mechanism information. We argue that mechanism metadata is relatively consistent across individuals exposed to similar amounts of mechanism information, and it is applicable to a wide range of causal systems. In three experiments, we show that adults and children as young as 5 years of age have a consistent sense of the causal complexity of different causal systems, and that this sense of complexity is related to decisions about when to seek expert knowledge, but over development there is a shift in focus from procedural information to internal mechanism information. 相似文献
36.
A unitary Neo-Piagetian/Neo-Eriksonian model of development: Fundamental assumptions and meta-issues
Gerald Young 《New Ideas in Psychology》2012,30(2):241-249
The article briefly reviews a stage model of change in human development that integrates a Neo-Piagetian model and a Neo-Eriksonian model into one unitary stage model across the lifespan (as presented in Young, 2011). The model suggests a generic model of stages in change. The article explores the fundamental assumptions underlying the model as well as considering meta-issues. The article adds to the book by describing the Neo-Eriksonian stages as reflections of a social “participatory” process. It adds to the change process in development by describing it as possibly reflecting “punctuated disequilibrium.” Finally, it adds a “multiple psychodynamics” model. 相似文献
37.
宗教与全球发展成为当代社会的一个重要议题,一个标志在于联合国千禧年发展目标的提出及世界宗教和精神领袖千禧年和平高峰会议。其中,由前世界银行行长及当时的坎特伯雷大主教联合发起的世界信仰发展对话,即为推动类似目标的一个重要机构。发展的目的在于人。贫困不仅包括物质的层面,也包括精神的层面。全球经济的发展需要一种伦理和价值的支撑。文化应该作为一种创新机制,参与并影响全球发展的过程。在中国,宗教是建设社会主义和谐社会的重要因素。中共十七大明确指出,要发挥宗教在社会经济发展中的重要作用。十七届六中全会则明确提出文化体制改革的目标。随着中国改革开放的进一步深入,中国对世界的影响日益加强,文化和精神的维度在社会发展和国家建设方面将扮演更重要的作用。中国模式也将对世界论坛的讨论产生一定影响。 相似文献
38.
Evidence-based methods for assisting consumers, such as counties, in successfully implementing practices are lacking in the field of implementation science. To fill this gap, the Community Development Teams (CDT) approach was developed to assist counties in developing peer networks focused on problem-solving and resource sharing to enhance their possibility of successful implementation. The CDT is an interactive, solution-focused approach that shares many elements of the Interactive Systems Framework (ISF) for Dissemination and Implementation. An ongoing randomized implementation trial of Multidimensional Treatment Foster Care (MTFC) was designed to test the hypothesis that such interactive implementation methods are more successful at helping counties achieve successful and sustainable MTFC programs than standard individualized implementation methods. Using the Stages of Implementation Completion measure, developed for this study, the potential benefit of these interactive methods is examined at different stages of the implementation process ranging from initial engagement to program competency. 相似文献
39.
Defever E Sasanguie D Gebuis T Reynvoet B 《Journal of experimental child psychology》2011,109(2):174-186
How people process and represent magnitude has often been studied using number comparison tasks. From the results of these tasks, a comparison distance effect (CDE) is generated, showing that it is easier to discriminate two numbers that are numerically further apart (e.g., 2 and 8) compared with numerically closer numbers (e.g., 6 and 8). However, it has been suggested that the CDE reflects decisional processes rather than magnitude representation. In this study, therefore, we investigated the development of symbolic and nonsymbolic number processes in kindergartners and first, second, and sixth graders using the priming paradigm. This task has been shown to measure magnitude and not decisional processes. Our findings revealed that a priming distance effect (PDE) is already present in kindergartners and that it remains stable across development. This suggests that formal schooling does not affect magnitude representation. No differences were found between the symbolic and nonsymbolic PDE, indicating that both notations are processed with comparable precision. Finally, a poorer performance on a standardized mathematics test seemed to be associated with a smaller PDE for both notations, possibly suggesting that children with lower mathematics scores have a less precise coding of magnitude. This supports the defective number module hypothesis, which assumes an impairment of number sense. 相似文献
40.
The present research examined the dynamic interplay between the framing of one's progress from an initial state toward an end state (i.e., framed as the distance traveled from the initial state to the current state -‘to-date’ versus framed as the distance left from the current state to the end state -‘to-go’) and construal level in influencing motivation in goal pursuit. In three experiments we found that both state and chronic differences in experienced construal level modulate the impact of progress framing on motivation at a specific stage in goal pursuit, i.e., when consumers are halfway between the initial and end state, but is less consequential at the initial or end stages. This modulation shows that type of framing only affected motivation of people with an abstract, but not a concrete mindset. Under these conditions, progress framed in terms of to-date produced increased motivation compared to a to-go frame. Moreover, perceived goal distance was found to mediate the impact of progress framing on motivation for individuals with an abstract, but not a concrete mindset. 相似文献