Phase II Clinical Development of New Drugs
暫譯: 新藥的第二階段臨床開發
Ting, Naitee, Chen, Ding-Geng, Ho, Shuyen
- 出版商: Springer
- 出版日期: 2018-12-12
- 售價: $4,820
- 貴賓價: 9.5 折 $4,579
- 語言: 英文
- 頁數: 241
- 裝訂: Quality Paper - also called trade paper
- ISBN: 9811350744
- ISBN-13: 9789811350740
海外代購書籍(需單獨結帳)
相關主題
商品描述
This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.
商品描述(中文翻譯)
本書專注於如何適當地規劃和開發第二階段計畫，以及如何設計第二階段臨床試驗並分析其數據。它提供了整個藥物開發過程的全面概述，並強調了在成功執行第二階段時需要解決的關鍵問題，以提高其在第三階段和藥物批准中的成功率。最後，它提醒專案團隊成員注意常見的潛在陷阱，並提供避免這些陷阱的建議。
作者簡介
Naitee Ting is a Fellow of ASA. He is currently a Director in the Department of Biostatistics and Data Sciences at Boehringer-Ingelheim Pharmaceuticals Inc. (BI). He joined BI in September of 2009, and before joining BI, he was at Pfizer Inc. for 22 years (1987-2009). Naitee received his Ph.D. in 1987 from Colorado State University (major in Statistics). He has an M.S. degree from Mississippi State University (1979, Statistics) and a B.S. degree from College of Chinese Culture (1976, Forestry) at Taipei, Taiwan. Naitee published articles in Technometrics, Statistics in Medicine, Drug Information Journal, Journal of Statistical Planning and Inference, Journal of Biopharmaceutical Statistics, Biometrical Journal, Statistics and Probability Letters, and Journal of Statistical Computation and Simulation. His book "Dose Finding in Drug Development" was published in 2006 by Springer, and is considered as the leading reference in the field of dose response clinical trials. The book "Fundamental Concepts for New Clinical Trialists," co-authored with Scott Evans, was published by CRC in 2015. Naitee is an adjunct professor of Columbia University, University of Connecticut and University of Rhode Island. Naitee has been an active member of both the American Statistical Association (ASA) and the International Chinese Statistical Association (ICSA).
Professor Ding-Geng Chen is a fellow of the American Statistical Association and currently the Wallace Kuralt distinguished professor at the University of North Carolina at Chapel Hill, USA, and an extraordinary professor at University of Pretoria, South Africa. He was a professor at the University of Rochester and the Karl E. Peace endowed eminent scholar chair in biostatistics at Georgia Southern University. He is also a senior consultant for biopharmaceuticals and government agencies with extensive expertise in clinical trial biostatistics and public health statistics. Professor Chen has written more than 150 referred publications and co-authored/co-edited twelve books on clinical trial methodology with R and SAS, meta-analysis using R, advanced statistical causal-inference modeling, Monte-Carlo simulations, advanced public health statistics and statistical models in data science. Shuyen Ho received his PhD in Statistics from University of Wisconsin - Madison, and his Bachelor in Applied Mathematics from Taiwan. Dr. Ho is a Biostatistics Director at PAREXEL International in Durham, North Carolina and has worked in the pharmaceutical industry for over 25 years. Prior to PAREXEL, he was a Clinical Statistics Director at GlaxoSmithKline (GSK) and Group Leader at Merck. He specializes in Phase II & III clinical development and has helped developed widely used respiratory medicines such as Claritin, Advair and Veramyst. Joseph C. Cappelleri earned his MS in statistics from the City University of New York (Baruch College), PhD in psychometrics from Cornell University, and MPH in epidemiology from Harvard University. Dr. Cappelleri is a senior director of biostatistics at Pfizer Inc. He has also served on the adjunct faculties at Brown University, Tufts Medical Center, and the University of Connecticut. A Fellow of the American Statistical Association, he has delivered numerous conference presentations and published extensively on clinical and methodological topics, including regression-discontinuity designs, meta-analysis, and health measurement scales. Dr. Cappelleri is the lead author of the book "Patient-Reported Outcomes: Measurement, Implementation and Interpretation."
Professor Ding-Geng Chen is a fellow of the American Statistical Association and currently the Wallace Kuralt distinguished professor at the University of North Carolina at Chapel Hill, USA, and an extraordinary professor at University of Pretoria, South Africa. He was a professor at the University of Rochester and the Karl E. Peace endowed eminent scholar chair in biostatistics at Georgia Southern University. He is also a senior consultant for biopharmaceuticals and government agencies with extensive expertise in clinical trial biostatistics and public health statistics. Professor Chen has written more than 150 referred publications and co-authored/co-edited twelve books on clinical trial methodology with R and SAS, meta-analysis using R, advanced statistical causal-inference modeling, Monte-Carlo simulations, advanced public health statistics and statistical models in data science. Shuyen Ho received his PhD in Statistics from University of Wisconsin - Madison, and his Bachelor in Applied Mathematics from Taiwan. Dr. Ho is a Biostatistics Director at PAREXEL International in Durham, North Carolina and has worked in the pharmaceutical industry for over 25 years. Prior to PAREXEL, he was a Clinical Statistics Director at GlaxoSmithKline (GSK) and Group Leader at Merck. He specializes in Phase II & III clinical development and has helped developed widely used respiratory medicines such as Claritin, Advair and Veramyst. Joseph C. Cappelleri earned his MS in statistics from the City University of New York (Baruch College), PhD in psychometrics from Cornell University, and MPH in epidemiology from Harvard University. Dr. Cappelleri is a senior director of biostatistics at Pfizer Inc. He has also served on the adjunct faculties at Brown University, Tufts Medical Center, and the University of Connecticut. A Fellow of the American Statistical Association, he has delivered numerous conference presentations and published extensively on clinical and methodological topics, including regression-discontinuity designs, meta-analysis, and health measurement scales. Dr. Cappelleri is the lead author of the book "Patient-Reported Outcomes: Measurement, Implementation and Interpretation."
作者簡介(中文翻譯)
丁凱廷是美國統計學會的會士。他目前擔任Boehringer-Ingelheim Pharmaceuticals Inc. (BI)生物統計與數據科學部的主任。他於2009年9月加入BI，在此之前，他在Pfizer Inc.工作了22年（1987-2009）。丁凱廷於1987年在科羅拉多州立大學獲得統計學博士學位。他擁有密西西比州立大學的碩士學位（1979年，統計學）和台灣台北中國文化大學的學士學位（1976年，林學）。丁凱廷在《Technometrics》、《Statistics in Medicine》、《Drug Information Journal》、《Journal of Statistical Planning and Inference》、《Journal of Biopharmaceutical Statistics》、《Biometrical Journal》、《Statistics and Probability Letters》和《Journal of Statistical Computation and Simulation》等期刊上發表了多篇文章。他的著作《Dose Finding in Drug Development》於2006年由Springer出版，被視為劑量反應臨床試驗領域的主要參考書籍。與Scott Evans共同撰寫的書籍《Fundamental Concepts for New Clinical Trialists》於2015年由CRC出版。丁凱廷是哥倫比亞大學、康乃爾大學和羅德島大學的兼任教授。他是美國統計學會（ASA）和國際華人統計學會（ICSA）的活躍成員。
陳丁耕教授是美國統計學會的會士，目前擔任美國北卡羅來納大學教堂山分校的Wallace Kuralt傑出教授，以及南非比勒陀利亞大學的特聘教授。他曾在羅徹斯特大學任教，並擔任喬治亞南方大學的Karl E. Peace生物統計學傑出學者椅。他還是生物製藥和政府機構的高級顧問，擁有臨床試驗生物統計學和公共衛生統計學的豐富專業知識。陳教授已發表超過150篇經審查的出版物，並與他人共同撰寫/編輯了十二本關於臨床試驗方法論的書籍，涵蓋R和SAS的應用、使用R的元分析、高級統計因果推斷建模、蒙地卡羅模擬、高級公共衛生統計學和數據科學中的統計模型。
