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New Medicines: How Drugs Are Created, Approved, Marketed and Sold » (New Edition)

Book cover image of New Medicines: How Drugs Are Created, Approved, Marketed and Sold by Bernice Schacter

Authors: Bernice Schacter
ISBN-13: 9780275981419, ISBN-10: 027598141X
Format: Hardcover
Publisher: Greenwood Publishing Group, Incorporated
Date Published: March 2006
Edition: New Edition

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Author Biography: Bernice Schacter

BERNICE SCHACTER Ph.D., has over 25 years of biomedical research experience in both academia and industry. She served on the faculty of the School of Medicine of Case Western Reserve University and conducted immunology research at Bristol-Myers Squibb Company. She also served as Vice President of Research at BioTransplant, Inc., a biotechnology startup company in Boston, MA. She has published over 50 papers in peer-reviewed journals and is a co-inventor on four issued patents. Since 1994 she has been a biomedical consultant and writer. She has taught immunology to undergraduate, graduate, and medical students and has developed and offered biotechnology courses for liberal studies students at Wesleyan University in Connecticut and at the University of Delaware.

Book Synopsis

Schacter, a biomedical consultant, leads readers through the maze of the modern drug industry, explaining step by step how new medicines are invented, tested, and regulated. Writing in plain language for the general reader, she looks at controversies surrounding the rise and fall of the COX-2 inhibitors, the strengths and weaknesses of the Food and Drug Administration approval process, and the pharmaceutical industry's new marketing techniques. Annotation © 2006 Book News, Inc., Portland, OR

Table of Contents

1The path from bench to bedside1
2How did the FDA get to be in charge? : the history of regulation of human drugs13
3The eureka moment : how new medicines are discovered21
4Test tube results are not enough : animal tests for a drug's utility37
5The business decisions : committing to development47
6Production of the new drug57
7Laboratory and animal safety testing65
8Getting set for clinical trials81
9Phase 1 clinical trials93
10Phase 2 clinical testing101
11Phase 3 testing113
12Putting together the application for approval : the new drug application (NDA)123
13Everybody holds their breath : will the FDA file the NDA?135
14The FDA review143
15What do outside experts think? : the advisory committee meeting and FDA approval161
16The launch : marketing the drug181
17It's not over till it's over : post-approval studies201
18Are we (well) served? do we have the system, industry, and regulations we need, want, and deserve?223

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