The new medicines : how drugs are created, approved, marketed, and sold - Schacter, Bernice Zeldin, 1943- (Westport, Conn. : Praeger, 2006)
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 forapproval: 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.
Includes bibliographical references (p. [237]-257) and index.
Keywords: Drug development -- Popular works; Clinical trials -- Popular works; Pharmaceutical industry -- Popular works; Consumer education; Drug Industry -- organization & administration -- United States; Pharmaceutical Preparations -- economics -- United States; Clinical Trials -- United States; Drug Design -- United States; Drugs, Investigational -- economics -- United States; Legislation, Drug -- United States