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Guide to Drug Development: A Comprehensive Review & Assessment (Hardcover)

by Bert Spilker (Author)
Key Phrases: product license application, require legal input, transferring discoveries, United States, New York, Raven Press (more...)

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Product Description

Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

Product Details

Hardcover: 1232 pages
Publisher: Lippincott Williams & Wilkins; 1 edition (September 1, 2008)
Language: English
ISBN-10: 0781774241
ISBN-13: 978-0781774246
Product Dimensions: 11.1 x 8.7 x 2 inches
Shipping Weight: 6.2 pounds (View shipping rates and policies)
Average Customer Review: No customer reviews yet. Be the first.
Amazon.com Sales Rank: #242,119 in Books (See Bestsellers in Books)
Popular in this category: (What's this?)
#4 in Books > Professional & Technical > Medical > Pharmacology > Product Development

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Inside This Book (learn more)

Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
product license application, require legal input, transferring discoveries, animal toxicity studies, competitive intelligence, surrogate endpoints, high medical value, virtual drug development, drug discovery period, chemical scaleup, investigational period, product information group, minimally acceptable criteria, pharmacoeconomic trials, life events data, compassionate trial, final medical report, regulatory meetings, meetings with regulatory agencies, avoiding tangents, podium policy, drug discovery activities, vestigational drugs, pharmaceutical trade associations, compassionate use trial

Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, Raven Press, New Drug Application, Institutional Review Board, United Kingdom, International Conference, European Union, Advisory Committee, National Institutes of Health, Ethics Committee, Working Group, Boca Raton, World Health Organization, Burroughs Wellcome Company, Good Clinical Practices, Chief Executive Officer, National Academies Press, Additional Readings, Good Manufacturing Practices, Data Safety Monitoring Board, John Wiley, Oxford University Press, Good Laboratory Practices, Institute of Medicine Board

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