<p>真是好书 只是经济板上欣赏的人可能不多</p><p>【书名】 STATISTICS IN DRUG RESEARCH: METHODOLOGIES AND<br/>RECENT DEVELOPMENTS<br/>【作者】SHEIN-CHUNG CHOW, JUN SHAO 看名字是兩個中国人<br/>【出版社】Marcel Dekker<br/>【版本】1<br/>【出版日期】2002<br/>【文件格式】PDF</p><p>【文件大小】18.3Mb<br/>【页数】372 including cover <br/>【ISBN出版号】ISBN: 0-8247-0763-X<br/>【资料类别】葯理學 统计学<br/>【市面定价】USD 199<br/>【扫描版还是影印版】original<br/>【是否缺页】complete <br/>【关键词】experimental design, statistics, clinical trial<br/>【内容简介】The book covers all essential elements of conducting a clinical trial. From legistation regulation, phamacological evaluation, and statistical solution of major problems that might happen in clinical trials. <br/>【目录】</p><p>Contents<br/>Series Introduction<br/>Preface<br/>Chapter 1. Introduction<br/>Chapter 2.Pharmaceutical Validation<br/>Chapter 3. Dissolution Testing<br/>Chapter 4. Stability analysis</p><p>Chapter 5. Bioavailability and Bioequivalence</p><p>Chapter 6. Randomization and Blinding</p><p>Chapter 7. Substantial Evidence in Clinical Development</p><p>Chapter 8. Therapeutic Equivalence and Noninferiority</p><p>Chapter 9. Analysis of Incomplete Data</p><p>Chapter 10. Meta-Analysis </p><p>Chapter 11. Quality of Life</p><p>Chapter 12. Medical Imaging</p><p>references</p><p>【原创书评】這本書的主題就算是英文也算少見. 中文的更找不到. clinical trial 牽涉的層面相當廣泛. 相關的法律規範也很厳謹. 近年來很多trial 都到中國來進行,為的是了解藥物對亞洲人的效果與反應, 以利亞洲銷售業務的推展. 所以了解clinical trial 的內涵對相關產業非常重要.</p><p>學生物與醫學的朋友會從本書中得到好處,本書以相當篇幅介紹GCP規範,然後介紹了幾種基本的實驗設計方式,統計建模的選擇,以及遇到問題時的解決方式.全書並不預設高深的統計知識(需要multivariate analysis),也有舉例說明. 書寫風格以介紹實際應用為主, 不偏重数理統計的証明.</p>
[此贴子已经被作者于2008-2-12 18:29:26编辑过]