Calculation of Tolerance Limits and Sample Size Determination for Clinical Trials with Dichotomous Outcomes

Boris G. Zaslavsky

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Calculation of Tolerance Limits and Sample Size Determination for Clinical Trials with Dichotomous Outcomes

机译：有二分结果的临床试验的耐受极限的计算和样本量的确定

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摘要

This research provides an algorithm for calculating uniformly most accurate tolerance intervals in clinical trials with dichotomous outcomes. The link between confidence intervals for proportions and tolerance intervals for numbers of outcomes is established. Tolerance intervals and sample size estimates for clinical trials may be calculated using StatXact.

机译：这项研究提供了一种算法，用于在具有二分结果的临床试验中统一计算最准确的耐受间隔。建立了比例的置信区间与结果数量的容忍区间之间的联系。可以使用StatXact计算临床试验的耐受间隔和样本量估计。

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《Journal of biopharmaceutical statistics》 |2007年第3期|共11页
作者
Boris G. Zaslavsky;
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正文语种 eng
中图分类药学;
关键词
Binomial distribution; Clinical trial; Confidence probability; Dichotomous outcome; Negative-binomial distribution; Tolerance limit;

机译：二项式分布;临床试验;置信概率;二分结果;负二项式分布;耐受极限;

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专利

1. Calculation of Tolerance Limits and Sample Size Determination for Clinical Trials with Dichotomous Outcomes [J] . Boris G. Zaslavsky Journal of biopharmaceutical statistics . 2007,第3期

机译：有二分结果的临床试验的耐受极限的计算和样本量的确定
2. Sample Size Calculation for Dichotomous Outcomes in Cluster Randomization Trials with Varying Cluster Size [J] . Seung-Ho Kang, Chul W. Ahn, Sin-Ho Jung Drug information journal . 2003,第1期

机译：聚类大小可变的聚类随机试验中二分结果的样本大小计算
3. Bayesian Sample Size Estimates for One Sample Test in Clinical Trials With Dichotomous and Countable Outcomes [J] . Boris G. Zaslavsky Statistics in Biopharmaceutical Research . 2012,第1期

机译：具有二分和可数结果的临床试验中一项样本测试的贝叶斯样本量估计
4. MKL-Based Sample Enrichment and Customized Outcomes Enable Smaller AD Clinical Trials [C] . Chris Hinrichs, N. Maritza Dowling, Sterling C. Johnson, International workshop on machine learning and interpretation in neuroimaging;Conference on neural information processing . 2012

机译：基于MKL的样品富集和定制结果可进行较小的AD临床试验
5. Applying survival analysis techniques to interim analysis and sample size reassessment of clinical trials with a dichotomous endpoint. [D] . Pedley, Alison L. 2011

机译：将生存分析技术应用于具有二分终点的临床试验的中期分析和样本量重新评估。
6. Assessing accuracy of Weibull shape parameter estimate from historical studies for subsequent sample size calculation in clinical trials with time-to-event outcome [O] . Milind A. Phadnis, Palash Sharma, Nadeesha Thewarapperuma, 2020

机译：评估历史研究中威布尔形状参数估计值的准确性以便随后在具有事件发生时间的临床试验中计算后续样本量
7. Sample size determination for quadratic inference functions in longitudinal design with dichotomous outcomes [O] . Hu Youna, Song Peter X.‐k. 2012

机译：在二次结果的纵向设计中确定二次推理函数的样本大小
8. Determination of Sample Sizes for Setting Beta-Content Tolerance Limits Controlling Both Tails of the Normal Distribution [R] . Chou, Y. M., Mee, R. W. 1984

机译：确定用于设置β-内容容差限制的样本大小控制正态分布的两个尾部

Calculation of Tolerance Limits and Sample Size Determination for Clinical Trials with Dichotomous Outcomes

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