TY  - BOOK
AU  - Schacter,Bernice Zeldin
TI  - The new medicines: how drugs are created, approved, marketed, and sold 
SN  - 027598141X : HRD
AV  - RM301.25 .S34 2006
U1  - 615/.19 22
PY  - 2006///
CY  - Westport, Conn.
PB  - Praeger
KW  - Drug development
KW  - Popular works
KW  - Clinical trials
KW  - Pharmaceutical industry
KW  - Consumer education
KW  - Drug Industry
KW  - organization & administration
KW  - United States
KW  - Pharmaceutical Preparations
KW  - economics
KW  - Clinical Trials
KW  - Drug Design
KW  - Drugs, Investigational
KW  - Legislation, Drug
N1  - 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
UR  - http://www.loc.gov/catdir/toc/ecip0515/2005019187.html
ER  -