Drugs from Discovery to Approval - Rilegato

Ng, Rick, Ph.D.

4,12

49 valutazioni di Goodreads

9780471601500: Drugs from Discovery to Approval

Rilegato

ISBN 10: 0471601500 ISBN 13: 9780471601500

Casa editrice: Wiley-Liss, 2004

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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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Recensione:

" ideal for researchers who want a basic, unadorned presentation of drug research and development." ( Journal of Clinical Research Best Practices, October 2007)

" 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)

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)

"...a concise guide to the subject...readable and clearly written...can be recommended for the general reader..." (Pharmaceutical Journal, 24 April 2004)

L'autore:

Rick Ng, Ph.D., has worked for more than 20 years in senior management positions in the private sector. He is currently a senior manager at a biopharmaceutical manufacturing facility in Singapore. He has provided technical training for graduate and post-graduate personnel.

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