The new medicines : how drugs are created, approved, marketed, and sold
著者
書誌事項
The new medicines : how drugs are created, approved, marketed, and sold
Praeger, 2006
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注記
Includes bibliographical references (p. [237]-257) and index
HTTP:URL=http://www.loc.gov/catdir/toc/ecip0515/2005019187.html Information=Table of contents
収録内容
- 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
