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

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

by Bernice Z. Schacter
ISBN-10:
027598141X
ISBN-13:
9780275981419
Pub. Date:
12/30/2005
Publisher:
Bloomsbury Academic
ISBN-10:
027598141X
ISBN-13:
9780275981419
Pub. Date:
12/30/2005
Publisher:
Bloomsbury Academic
The New Medicines: How Drugs are Created, Approved, Marketed, and Sold

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

by Bernice Z. Schacter

Hardcover

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Overview

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?


Product Details

ISBN-13: 9780275981419
Publisher: Bloomsbury Academic
Publication date: 12/30/2005
Edition description: New Edition
Pages: 280
Product dimensions: 6.30(w) x 9.20(h) x 0.90(d)

About 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 jourbanals 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.

Table of Contents

List of Illustrations
Preface
Abbreviations and Acronyms
The Path from Bench to Bedside
How did the FDA get to be in charge? The History of Human Drugs
The Eureka Moment: How New Medicines Are Discovered
Test Tube Results Are Not Enough - Animal Tests for a Drug's Utility
The Business Decisions - Committing to Development
Production of the New Drug
Laboratory and Animal Safety Testing
Getting Set for Clinical Trials
Phase 1 Clinical Trials
Phase 2 Clinical Testing
Phase 3 Testing
Putting Together the Application for Approval: The New Drug Application (NDA)
Now Everybody Holds Their Breath (and some people may brush up on the rules for insider trading) - Will the FDA File the NDA?
The FDA Review
What do outside experts think? The Advisory Committee Meeting and FDA Approval
The Launch: Marketing the Drug
It's Not Over Till It's Over: Post Approval Studies
Are we well served?

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