Image from Coce

The new medicines : how drugs are created, approved, marketed, and sold / Bernice Schacter.

By: Material type: TextTextPublisher: Westport, Conn. : Praeger, 2006Description: xi, 267 pages ; 25 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 027598141X
  • 9780275981419
Subject(s): DDC classification:
  • 615.19 22
LOC classification:
  • RM301.25 .S34 2006
Contents:
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.
Summary: Includes information on Celebrex, Copaxone, Food and Drug Administration, Erbitux, etc.
Tags from this library: No tags from this library for this title. Log in to add tags.
Holdings
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

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.

There are no comments on this title.

to post a comment.

Powered by Koha