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21.
Modelling PK/QT relationships from Phase I dose‐escalation trials for drug combinations and developing quantitative risk assessments of clinically relevant QT prolongations 下载免费PDF全文
In current industry practice, it is difficult to assess QT effects at potential therapeutic doses based on Phase I dose‐escalation trials in oncology due to data scarcity, particularly in combinations trials. In this paper, we propose to use dose‐concentration and concentration‐QT models jointly to model the exposures and effects of multiple drugs in combination. The fitted models then can be used to make early predictions for QT prolongation to aid choosing recommended dose combinations for further investigation. The models consider potential correlation between concentrations of test drugs and potential drug–drug interactions at PK and QT levels. In addition, this approach allows for the assessment of the probability of QT prolongation exceeding given thresholds of clinical significance. The performance of this approach was examined via simulation under practical scenarios for dose‐escalation trials for a combination of two drugs. The simulation results show that invaluable information of QT effects at therapeutic dose combinations can be gained by the proposed approaches. Early detection of dose combinations with substantial QT prolongation is evaluated effectively through the CIs of the predicted peak QT prolongation at each dose combination. Furthermore, the probability of QT prolongation exceeding a certain threshold is also computed to support early detection of safety signals while accounting for uncertainty associated with data from Phase I studies. While the prediction of QT effects is sensitive to the dose escalation process, the sensitivity and limited sample size should be considered when providing support to the decision‐making process for further developing certain dose combinations. Copyright © 2016 John Wiley & Sons, Ltd. 相似文献
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Brink KS 《Work (Reading, Mass.)》2007,29(1):47-53
The assessment of malingering has predominantly been considered within the domains of neuropsychologists and psychiatrists, who use consistency of performance criteria similar to those used in functional capacity evaluations (FCE). The use of activity has traditionally been used in occupational therapy as an assessment and treatment modality with goals not always considered obvious and which could easily be used for diversional reasons. The appropriate use of activity adds an additional dimension to a layered approach of using multiple data sources and methods as recommended by FCE practitioners and neuropsychologists alike. The case illustration aims to explain the above using a layered model. 相似文献
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The purpose of this study was to determine the degree to which a novel training program based on activities of daily living (ADL) would affect performance of ADLs, as well as the fitness of older adults. Fourteen individuals (mean age 82 years) took part in a 10-week control period followed by a 10-week ADL-based training program. Pre- and posttests included the Physical Performance Test (PPT), the Physical Functional Performance-10 (PFP-10), and the Senior Fitness Test (SFT). After the training period, improvements ranging from 7% to 33% (p<.05) were seen on the PPT and PFP-10 and on three items of the SFT. After conversion to standard scores, the magnitude of change in the PPT and the PFP10 was significantly greater (p<.05) than the magnitude of change in the SFT. These data support the idea that this novel ADL-based training program was able to facilitate improved performance of ADLs, as well as select measures of fitness among older adults. 相似文献
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Wolf-Branigin M Wolf-Branigin K Israel N 《Journal of social work in disability & rehabilitation》2007,6(4):15-30
Recruiting and retaining direct support professionals (DSPs) remains essential to the full inclusion for persons with disabilities. Using a mixed-evaluation model, we measured DSPs' views versus those of their supervisors. DSPs expressed lower perceptions concerning their supervisors, satisfaction with their work situation, and environmental and safety factors. Focus groups provided insights into resolving issues related to compensation, work environment, and recruiting and retaining future DSPs. Motivating factors included wanting to be part of a helping community where all are valued. To improve their performance, DSPs stated their desire to understand the roles of managers and of the consumer. DSPs indicated that having career paths that provided advancement opportunities and direct contact with persons with disabilities were primary motivators. 相似文献
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