Authors: Bernice Schacter
ISBN-13: 9780275981419, ISBN-10: 027598141X
Format: Hardcover
Publisher: Greenwood Publishing Group, Incorporated
Date Published: March 2006
Edition: New Edition
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.
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
1 | The path from bench to bedside | 1 |
2 | How did the FDA get to be in charge? : the history of regulation of human drugs | 13 |
3 | The eureka moment : how new medicines are discovered | 21 |
4 | Test tube results are not enough : animal tests for a drug's utility | 37 |
5 | The business decisions : committing to development | 47 |
6 | Production of the new drug | 57 |
7 | Laboratory and animal safety testing | 65 |
8 | Getting set for clinical trials | 81 |
9 | Phase 1 clinical trials | 93 |
10 | Phase 2 clinical testing | 101 |
11 | Phase 3 testing | 113 |
12 | Putting together the application for approval : the new drug application (NDA) | 123 |
13 | Everybody holds their breath : will the FDA file the NDA? | 135 |
14 | The FDA review | 143 |
15 | What do outside experts think? : the advisory committee meeting and FDA approval | 161 |
16 | The launch : marketing the drug | 181 |
17 | It's not over till it's over : post-approval studies | 201 |
18 | Are we (well) served? do we have the system, industry, and regulations we need, want, and deserve? | 223 |