The new medicines : how drugs are created, approved, marketed, and sold /
Bernice Schacter.
- Westport, Conn. : Praeger, 2006.
- xi, 267 p. ; 25 cm.
Includes bibliographical references (p. [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 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.
027598141X : HRD $44.95 9780275981419
Greenwood Pub Group, C/O Harcourt Education 465 S Lincoln Dr, Troy, MO, USA, 63379, (203)2263571-3352 nSAN 210-5829
2005019187
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.