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- 2005019187 contributor B10126979.
- 2005019187 created "2006.".
- 2005019187 date "2006".
- 2005019187 date "2006.".
- 2005019187 dateCopyrighted "2006.".
- 2005019187 description "Includes bibliographical references (p. [237]-257) and index.".
- 2005019187 description "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.".
- 2005019187 extent "xi, 267 p. ;".
- 2005019187 identifier "027598141X (alk. paper)".
- 2005019187 identifier 2005019187.html.
- 2005019187 issued "2006".
- 2005019187 issued "2006.".
- 2005019187 language "eng".
- 2005019187 publisher "Westport, Conn. : Praeger,".
- 2005019187 spatial "United States.".
- 2005019187 subject "615/.19 22".
- 2005019187 subject "Clinical Trials United States.".
- 2005019187 subject "Clinical trials Popular works.".
- 2005019187 subject "Consumer education.".
- 2005019187 subject "Drug Design United States.".
- 2005019187 subject "Drug Industry organization & administration United States.".
- 2005019187 subject "Drug development Popular works.".
- 2005019187 subject "Drugs, Investigational economics United States.".
- 2005019187 subject "Legislation, Drug United States.".
- 2005019187 subject "Pharmaceutical Preparations economics United States.".
- 2005019187 subject "Pharmaceutical industry Popular works.".
- 2005019187 subject "QV 736 S291n 2006".
- 2005019187 subject "RM301.25 .S34 2006".
- 2005019187 tableOfContents "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.".
- 2005019187 title "The new medicines : how drugs are created, approved, marketed, and sold / Bernice Schacter.".
- 2005019187 type "text".