New Medicines: How Drugs Are Created, Approved, Marketed and Sold
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...
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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
1The path from bench to bedside12How did the FDA get to be in charge? : the history of regulation of human drugs133The eureka moment : how new medicines are discovered214Test tube results are not enough : animal tests for a drug's utility375The business decisions : committing to development476Production of the new drug577Laboratory and animal safety testing658Getting set for clinical trials819Phase 1 clinical trials9310Phase 2 clinical testing10111Phase 3 testing11312Putting together the application for approval : the new drug application (NDA)12313Everybody holds their breath : will the FDA file the NDA?13514The FDA review14315What do outside experts think? : the advisory committee meeting and FDA approval16116The launch : marketing the drug18117It's not over till it's over : post-approval studies20118Are we (well) served? do we have the system, industry, and regulations we need, want, and deserve?223
