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Drugs: From Discovery to Approval
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"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." —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.
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Product details
Hardcover: 480 pages
Publisher: Wiley-Blackwell; 2 edition (December 3, 2008)
Language: English
ISBN-10: 9780470195109
ISBN-13: 978-0470195109
ASIN: 047019510X
Product Dimensions:
6.5 x 1.2 x 9.6 inches
Shipping Weight: 1.8 pounds (View shipping rates and policies)
Average Customer Review:
4.6 out of 5 stars
5 customer reviews
Amazon Best Sellers Rank:
#852,330 in Books (See Top 100 in Books)
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.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.
A solid reference book for those not professional in regulatory affairs. Clear and objective. Needs revision.
Good book. Explains very thoroughly .
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!
Avicenna and Rhazes were Persian not Arab!Unfortunately, in A1.2.2 of second edition, it is written:Through trade with many regions, the Arabians learned and extended medical knowledge. Their major contribution is perhaps the knowledge of medicalpreparations and distillation methods, although the techniques were probablyderived from the practices of alchemists. Avicenna, around ad 900 – 1000,recorded a vast encyclopedia of medical description and treatment. Anothernoted physician was Rhazes, who accurately described measles and smallpox.
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