Drugs-From Discovery to Approval

by Rick Ng (Author)

Editorial Reviews

"…ideal for researchers who want a basic, unadorned presentation of drug
research and development." (Journal of Clinical Research Best Practices, October

"…a concise, no-nonsense overview of drug research and development from target
identification to product manufacturing." (Journal of Clinical Research
Practices, October 2007)

“…an exciting and novel text…excellent and essential text…” (Journal of Chemical
Technology and Biotechnology, Vol. 80 (8), August 2005)

“…an exciting and novel text …provides a concise, yet comprehensive survey of
the entire drug development process.” (Journal of Chemical Technology and
Biotechnology, 2005; Vol. 80, 964-965)

“…a practical reference source on this important process.” (Journal of the
National Medical Association, Vol.97, No.3, March 2005)

"…this book is appealing...the information...should provide a greater
understanding of social and ethical concerns regarding modern medications in a
complex world." (Journal of Pharmacy Technology, November/ December 2004)
"...a concise guide to the subject...readable and clearly written...can be
recommended for the general reader..." (Pharmaceutical Journal, 24 April 2004)

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.

Product Details

Hardcover: 368 pages
Publisher: Wiley-Liss; 1 edition (January 2, 2004)
Language: English
ISBN-10: 0471601500



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