(2 reviews) Author: ISBN : 9780470195109 New from $70.79 Format: PDF—Doody's Reviews, May 2009
"The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials."
—Chemistry World, February 2009
The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.
This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.
Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.
- Hardcover: 480 pages
- Publisher: Wiley-Blackwell; 2 edition (December 3, 2008)
- Language: English
- ISBN-10: 047019510X
- ISBN-13: 978-0470195109
- Product Dimensions: 1.1 x 6 x 9.5 inches
- Shipping Weight: 1.8 pounds (View shipping rates and policies)
Drugs: From Discovery to Approval PDF
—Doody's Reviews, May 2009
"The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials."
—Chemistry World, February 2009
The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.
This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.
Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.
I work as an account manager in the Life Sciences vertical of an ITES organisation. I have been in the system for quite some time and had gained understanding of some of the key Pharmaceutical business fucntion.By Pankaj Shukla
This book particularly helped me to understand the full landscape and gain overall perpective. I would recommend this to anyone who has some or no business function knowledge and is wanting to consolidate. I would also recommend you to note down the points that are of interest to you and weave them in your own Pharma story.
I have now picked up Manual of Drug Safety And Pharmacovigilance. I am hoping this book would be as interesting as the earlier one.
I have a chem/biochem background and am about to finish my PhD. This book was great help for preparing for interviews in the pharmaceutical industry. Especially if you do not know anything about drug development, clinical trials and GxP regulations it is worth the money!By M. Zimmermann
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