Introduction to Statistics in Pharmaceutical Clinical Trials

Introduction to Statistics in Pharmaceutical Clinical Trials pdf epub mobi txt 电子书 下载 2026

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出版者:
作者:Durham, Todd A./ Turner, J. Rick
出品人:
页数:320
译者:
出版时间:2008-1
价格:$ 62.15
装帧:
isbn号码:9780853697145
丛书系列:
图书标签:
  • Statistics
  • Pharmaceutical
  • Clinical Trials
  • Biostatistics
  • Drug Development
  • Trial Design
  • Data Analysis
  • Regulatory Affairs
  • Healthcare
  • Research Methodology
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具体描述

This book is a self-contained introduction to Statistics, presented in the context of clinical trials and pharmaceutical drug development. It focuses on the statistical analyses most commonly used in drug development and is therefore an ideal introduction to pharmaceutical statistics. Instead of introducing a series of statistical techniques, the book's organizational structure follows the order in which numerical information and statistical analyses are used in trials and new drug development.All students taking classes in pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application and importance of Statistics. They need to understand:why, and how data are collected in clinical trials; 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 scientific and medical communities.This title therefore adopts a unique approach and concept in organization of the content. It begins with an introduction to statistical theory, analysis and interpretation. This is followed by a discussion of t-tests and confidence intervals. Readers are then taken through the whole process of new drug development (using one specific example throughout) that is meaningful in the context of their broader studies. Throughout this process, statistical techniques and analyses are introduced in the order in which they are employed during the process.The book's realistic scientific and progressive organization from pre-clinical trials to clinical pharmacology through clinical trials is novel, meaningful and educationally powerful. The book emphasises the importance of descriptive statistics as well as inferential statistics, something that is rarely done.Supplementary material is included for this text on the PharmPress website in the form of PowerPoint lecture notes on Statistics (based on content of this book) that can be downloaded by lecturers.

这本书致力于为读者系统地了解统计学在药物临床试验中的应用,其核心目标是帮助学习者深入理解研究设计、数据分析与结果解释之间的紧密联系。内容涵盖了从基础概念到复杂方法的广泛探讨,特别强调不同类型临床试验中统计工具的具体运用。书中详细介绍了随机化、对照组设置和样本量计算的重要性,同时引导读者掌握各种描述性统计技术以及如何通过数据可视化提升分析深度。此外,该书不仅系统讲解统计检验方法如t检验、方差分析及回归模型,还深入剖析了在处理不平衡数据、缺失值和多变量关系时所需的策略。这样的设计使读者能够将理论知识与实际研究情境相结合,具备解决真实临床试验问题的能力。 书中通过丰富的案例分析,帮助读者深入理解不同统计方法在不同场景下的优缺点和适用范围。例如,在药物疗效评价过程中,作者详细描述了如何利用假设检验判断实验结果是否具有显著性,并结合数据图表进行解释。这种通过实例讲解、理论梳理相结合的方式,使学习过程更为生动有力。此外,本书还特别注重统计与医学背景的融合,帮助读者理解每一项分析步骤背后的科学原理,而不仅仅停留在操作层面。这种对深度与广度并重的设计,确保读者不仅能掌握技术细节,更能培养批判性思维,学会独立判断数据意义。 书中内容结构严谨,章节分布合理,适用于临床研究人员、统计学初学者及希望提升专业素养的人士。每个部分都经过精心整理,从基本概念逐渐过渡到复杂分析,使得学习路径清晰明了。无论是新手还是有一定基础的读者,都能够通过这本书建立扎实的统计知识体系,并在实际研究或工作中灵活运用相关方法。这些内容不仅强调理论价值,更注重实践指导,帮助读者将所学转化为可操作的成果。 书中对统计误区和常见问题的详细解释,也为读者提供了重要的警示与提炼。这种对实际应用场景的关注,使读者不仅能够掌握技术手段,更能在真实数据环境下做出理性决策。通过系统性的学习,读者将具备更全面的统计素养,从而在面对复杂临床试验时拥有坚实的理论支撑和操作能力。这本书不仅是一本教材,更是提升科研水平、推动医学创新的重要工具。

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