Book

Schacter, Bernice, 1943-2008.

The new medicines : how drugs are created, approved, marketed, and sold / Bernice Schacter.

Westport, Conn. : Praeger, 2006.

xi, 267 pages ; 25 cm

Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc.

Drug development -- Popular works.

Clinical trials -- Popular works.

Pharmaceutical industry -- Popular works.

Consumer education.

Drugs -- Design.

Includes bibliographical references (pages 237-257) and index.

The path from bench to bedside -- How did the FDA get to be in charge? The history of regulation 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? Do we have the system of industry and regulations we need want and may deserve.

Table of contents

2005019187

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9780275981419

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