Introduction to Statistics in Pharmaceutical Clinical Trials

Winnie Seto

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Introduction to Statistics in Pharmaceutical Clinical Trials

机译：药物临床试验统计学概论

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Introduction to Statistics in Pharmaceutical Clinical Trials is an introductory statistics textbook intended to teach basic statistical concepts to students in pharmacy, allied health professions, and clinical research. In contrast to the usual format of introductory textbooks on this topic, the authors have presented the basic concepts in the context of clinical trials conducted during devel-opment of pharmaceutical drugs. This textbook explains why and how data are collected in clinical studies, how these data are summarized and analyzed, what the results mean in the context of the clinical research question, and how the results are communicated to regulatory agencies and to the scientific and medical communities.

机译：《药物临床试验统计学入门》是一本统计学入门书籍，旨在向药学，专职健康专业和临床研究的学生教授基本的统计概念。与有关该主题的入门教科书的通常格式相反，作者在药物开发过程中进行的临床试验中介绍了基本概念。这本教科书解释了为什么以及如何在临床研究中收集数据，如何对这些数据进行汇总和分析，结果在临床研究问题中的含义，以及如何将结果传达给监管机构以及科学和医学界。

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《The Canadian journal of hospital pharmacy.》 |2010年第1期|共2页
作者
Winnie Seto;
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正文语种 eng
中图分类药学;
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1. Introduction to Statistics in Pharmaceutical Clinical Trials [J] . Winnie Seto The Canadian journal of hospital pharmacy. . 2010,第1期

机译：药物临床试验统计学概论
2. Comments on 'The potential for bias in the reporting of industry sponsored clinical trials' by Stephen Pyke et al. and 'Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry sponsored clinical trials' by James Matcham et al. Pharmaceutical Statistics. [J] . Campbell MJ Pharmaceutical statistics. . 2011,第1期

机译：Stephen Pyke等人对“行业赞助的临床试验报告中可能存在的偏见”发表评论。 James Matcham等人的“在制药行业赞助的临床试验的报告和出版中统计学家的最佳实践建议”。药物统计。
3. Review: “PAREXEL’S Pharmaceutical R&D Statistical Sourcebook 2005/2006” and “State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics” [J] . Journal of Clinical Research Best Practices . 2005,第4期

机译：评论：“ PAREXEL的药物研发统计资料手册2005/2006”和“临床试验行业状况：图表统计资料手册”
4. A-share Stock Reactions to the Approval of COVID-19 Vaccine Clinical Trial: An Event Study Model of Listed Pharmaceutical Firms’ Returns [C] . Xiong Kewei, Liang Yuanyuan International Conference on Economic Management and Model Engineering . 2020

机译：A股股票反应对Covid-19疫苗临床试验的批准：列出的制药公司回报的事件研究模式
5. The impact of statistical method choice: Evaluation of the SANO randomized clinical trial using two non-traditional statistical methods. [D] . Lane, Christianne Joy. 2009

机译：统计方法选择的影响：使用两种非传统统计方法对SANO随机临床试验进行评估。
6. Introduction to Statistics in Pharmaceutical Clinical Trials [O] . Winnie Seto 2010

机译：药物临床试验统计学概论
7. Introduction to Statistics in Pharmaceutical Clinical Trials [O] . Seto, Winnie 2010

机译：药物临床试验统计学概论
8. Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Questions and Answers(R2), Revision 1. [R] . 2013

机译：行业指南：m3（R2）人体临床试验行为和药品营销许可的非临床安全性研究。问题与解答（R2），修订版1。

Introduction to Statistics in Pharmaceutical Clinical Trials

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