by Rick Ng
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Product Description
Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies.
Drugs-From Discovery to Approval presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future. Coverage also includes:
* A helpful listing of current FDA and European guidelines
* A special section on regulatory authorities and processes in Japan and China
* Rich illustrations throughout, including more than ninety figures and tables
* Useful appendices on the history of drug discovery and development
* Representative examples of drug mechanisms in action
Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, Drugs-From Discovery to Approval represents a practical and approachable reference on this important process.
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Average Customer Review:
0 of 0 people found the following review helpful:
 Good book to discover the world of drug discovery, 2008-08-03
If you are not a specialist in the field of drug discovery but need nevertheless to have a comprehensive knowledge of the process that starts at the discovery of a potential new drug and ends at the registration of the drug with a regulatory agency, this book is for you. The book is full of flowcharts and illustrations that help you to understand the process. It's certainly not a book for specialists, but can be really helpful for lawyers, contracts officers and everyone who works in the drug discovery industry.
0 of 0 people found the following review helpful:
A simple, yet comprehensive introduction, 2008-05-09
It's tough to learn quickly about the complexities of pharma R&D. This is a useful guide for those new to the industry and fills in the gaps for those more experienced. Like all books of its type, it will age quite rapidly in an sector undergoing rapid scientific and organizational change.
9 of 9 people found the following review helpful:
 An easy way to understand a complex process, 2006-08-21
I work in an organization that supports advanced gene therapy research that may lead to new therapies for chronic and life threatening diseases, but I am not a scientist. As a communicator, I needed to understand the long and arduous journey from discovery to pre-clinical research, to FDA-approved clinical manufacturing, and to human clinical trials. This book was excellent in helping me understand both the research and the regulatory environment.
The author says it best in the introduction, "The intention of this book is to provide an overview about how a drug is discovered, the amount of and types of laboratory tests that are performed, and the conduct of clinical trials before a drug is ready to registered for human use." The author also fully explains the role of regulatory authorities in these processes.
The book includes chapters on:
Drug discovery
Drug development and preclinical studies
Clinical trials
Good Manufacturing Practice
You'll also learn about things like toxicology studies, pharmacodynamics, and pharmacokinetics, and Investigational New Drug applications. Although the book contains some technical discussions and exhibits, the author has a logical and easy-to-understand way of presenting the information.
If, like me, you need to get a better understanding of process of getting basic drug research to the market, this book is for you.
10 of 11 people found the following review helpful:
Broad coverage with little in-depth detail, 2006-05-08
This book is written to cover a broad range of topics related to the drug discovery and approval process. Since so many topics are covered, there is very little in-depth coverage on any particular topic. It's suitable people who don't have any serious scientific training or experience in the industry. If you are looking for a high-level overview, this is a good book. If you would like more detailed information about any specific topic, you should probably look elsewhere. Some of the explaintions are over simplied in order for the average reader to understand. Much of the material covered in the book can be found in much greater detail by visiting the fda site or googling for the code of federal regulations. But if you do not what the FDA is or what CFR stands for, this book is probably right for you.
1 of 1 people found the following review helpful:
Good overview of the drug development and regulatory process, 2006-02-01
This is a very clear and concise review of the drug development process as well as the regulatory issues. It is well organized and well written. It is not a "behind the scenes" nitty-gritty book, but will help anyone who wants to understand the process.
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