The New Medicines: How Drugs are Created, Approved, Marketed, and Sold

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Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented? How do consumers know that drugs are safe and effective? How are they tested? Who regulates their production - and who watches the regulators? How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do? The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold.

In addition to explaining how drugs reach the medicine cabinet, the author - an experienced researcher and teacher - provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as: The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated. The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal. The strengths and weaknesses of the approval process of the Food and Drug Administration. The controversial new marketing techniques of the pharmaceutical industry. A balanced work that provides readers with an unbiased look at the drug industry, The New Medicines will answer the questions of anyone who has ever looked at a bottle of their prescription pills and wondered, how did that get here?

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Product Details

  • ISBN-13: 9780275981419
  • Publisher: ABC-CLIO, Incorporated
  • Publication date: 12/30/2005
  • Edition description: New Edition
  • Pages: 282
  • Sales rank: 724,742
  • Product dimensions: 6.30 (w) x 9.20 (h) x 0.90 (d)

Meet the Author

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.

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Table of Contents

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
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