This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
FREE Two-Day Shipping for students on millions of items. Learn more |
|
There is a newer edition of this item:
|
Book Description
Editorial Reviews
Review
"This volume would provide an excellent introduction for anyone entering the pharmaceutical industry. It would also make superb background reading for medical statistics for MSc students." (International Statistical Review, August 2008)
"This volume would provide an excellent introduction for anyone entering the pharmaceutical industry. It would also make superb background reading for medical statistics for MSc students." (International Statistical Review Aug 2008)
"The book gives a refreshing run through of the drug discovery and development process and it is probably the book you need to have to learn about this fascinating field." (Journal of Applied Statistics, January 2008)
"The author has the uncanny ability to reveal the essence of a complex topic without bogging down in superficialities." (Journal of Clinical Research Practices, September 2007)
From the Back Cover
Praise for New Drug Development
"I highly recommend this text as a comprehensive and very readable presentation of the process and nuances of new drug development. It is a concise and practical book that is well suited for several groups [including] individuals working in pharmaceutical drug development, healthcare providers, and students aspiring to work in either profession."
—Anita Flick, MD, Health Professions Advising, North Carolina State University
"Dr. Turner's book provides a panoramic overview of the complex process of new drug development, integrating discussions of drug discovery, nonclinical research, pre-approval clinical trials, and post-marketing surveillance. Students and professionals entering the worlds of pharmaceutical clinical research and medical practice will benefit greatly from this book, which is now required reading in our company."
—Anton-Lewis Usala, MD, President and CEO, Clinical Trials Management Group, Inc.
An indispensable and modern overview of the design concepts and statistical practices involved in therapeutic drug development
From the initial stages of identifying a potential drug candidate to receiving FDA approval, New Drug Development focuses on the collection, analysis, and interpretation of numerical representations of information throughout the drug development process. This timely text provides a self-contained overview of the new drug development process, while also emphasizing the importance of ethical, biological, social, and political considerations.
Using a relatively pragmatic approach, the author clearly illustrates how the discipline of statistics makes a central contribution to the complex process of new drug development, and these statistical issues are presented conceptually rather than computationally. This book features:
A realistic, scientific, and progressive organization from pre-clinical studies to clinical research that is educationally powerful
The discovery and development of new drugs using the latest advances in various fields, including molecular biology, computational chemistry and biology, computer-aided molecular design, proteomics, and bioinformatics
The design, methodology, and analysis essential for the development of drugs that succeed in safely treating diseases and conditions of clinical concern
New Drug Development is an essential guide for entry-level professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) industries as well as seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise.
Product Details
Would you like to update product info or give feedback on images?
|
More About the Author
Discover books, learn about writers, read author blogs, and more.
Customer Reviews
|
There are no customer reviews yet.
|
|||
|
Video reviews
|
Inside This Book
(learn more)
Key Phrases - Statistically Improbable Phrases (SIPs):
(learn more)
optimum quality data, therapeutic confirmatory trials, associated statistical analysis plan, compelling evidence that the drug, clinical drug products, group mean change score, dose treatment group, active comparator drug, preapproval clinical trials, superiority trials, regulatory toxicology studies, protein biopharmaceuticals, nonclinical development, therapeutic exploratory, drug treatment group, nonclinical research, noninferiority margin, investigative drug, nonclinical work, equivalence trials, placebo treatment group, group sequential designs, new antihypertensive drug, standardized effect size, new drug development Key Phrases - Capitalized Phrases (CAPs): (learn more)
John Wiley, Rick Turner Copyright, United States, Critical Path Opportunities List Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
optimum quality data, therapeutic confirmatory trials, associated statistical analysis plan, compelling evidence that the drug, clinical drug products, group mean change score, dose treatment group, active comparator drug, preapproval clinical trials, superiority trials, regulatory toxicology studies, protein biopharmaceuticals, nonclinical development, therapeutic exploratory, drug treatment group, nonclinical research, noninferiority margin, investigative drug, nonclinical work, equivalence trials, placebo treatment group, group sequential designs, new antihypertensive drug, standardized effect size, new drug development Key Phrases - Capitalized Phrases (CAPs): (learn more)
John Wiley, Rick Turner Copyright, United States, Critical Path Opportunities List Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Tag this product(What's this?)Think of a tag as a keyword or label you consider is strongly related to this product.
Tags will help all customers organize and find favorite items. |
Sell a Digital Version of This Book in the Kindle Store
If you are a publisher or author and hold the digital rights to a book, you can sell a digital version of it in our Kindle Store.
Learn more
Customer Discussions
|
This product's forum
Active discussions in related forums
Search Customer Discussions
|
Related forums
|
