TY  - BOOK
AU  - Schacter,Bernice
TI  - The new medicines: how drugs are created, approved, marketed, and sold 
SN  - 027598141X
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  - Administration
KW  - Drugs
KW  - Design
KW  - Pharmaceutical Preparations
KW  - economics
KW  - Drugs, Investigational
KW  - Legislation, Drug
KW  - Clinical Trials as Topic
KW  - United States
N1  - 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 --; 1. The path from bench to bedside -- 2. How did the FDA get to be in charge? The history of regulation of human drugs -- 3. The eureka moment: how new medicines are discovered -- 4. Test tube results are not enough: animal tests for a drug's utility -- 5. The business decisions: committing to development -- 6. Production of the new drug -- 7. Laboratory and animal safety testing -- 8. Getting set for clinical trials -- 9. Phase 1 clinical trials -- 10. Phase 2 clinical testing -- 11. Phase 3 testing -- 12. Putting together the application for approval: the new drug application (NDA) -- 13. Now everybody holds their breath (and some people may brush up on the rules for insider trading), will the FDA file the NDA? -- 14. The FDA review -- 15. What do outside experts think? The advisory committee meeting and FDA approval -- 16. The launch-marketing the drug -- 17. It's not over till it's over: post approval studies -- 18. Are we (well) served? Do we have the system of industry and regulations we need want and may deserve
N2  - Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc
ER  -