The new medicines : how drugs are created, approved, marketed, and sold / Bernice Schacter.
Material type: TextPublisher: Westport, Conn. : Praeger, 2006Description: xi, 267 pages ; 25 cmContent type:- text
- unmediated
- volume
- 027598141X
- 9780275981419
- Drug development -- Popular works
- Clinical trials -- Popular works
- Pharmaceutical industry -- Popular works
- Consumer education
- Pharmaceutical industry -- Administration
- Drugs -- Design
- Pharmaceutical Preparations -- economics
- Drugs, Investigational -- economics
- Legislation, Drug
- Clinical Trials as Topic
- United States
- 615.19 22
- RM301.25 .S34 2006
Item type | Current library | Call number | Copy number | Status | Date due | Barcode | |
---|---|---|---|---|---|---|---|
Book | North Campus North Campus Main Collection | 615.19 SCH (Browse shelf(Opens below)) | 1 | Available | A406146B |
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615.1401513 GAT Nursing calculations / | 615.19 ABR Abrams' clinical drug therapy : rationales for nursing practice / | 615.19 FRA Abrams' clinical drug therapy : rationales for nursing practice / | 615.19 SCH The new medicines : how drugs are created, approved, marketed, and sold / | 615.1900711 BUL Fundamentals of pharmacology / | 615.1900711 BUL Fundamentals of pharmacology / | 615.1900711 BUL Fundamentals of pharmacology / |
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.
Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc.
Machine converted from AACR2 source record.
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