An edition of The new medicines
(2006)
The new medicines
how drugs are created, approved, marketed, and sold
by Bernice Zeldin Schacter
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Previews available in: English
Subjects
Clinical trials, Consumer education, Drug Design, Drug Industry, Drug Legislation, Drug development, Economics, Investigational Drugs, Organization & administration, Pharmaceutical Preparations, Pharmaceutical industry, Popular works, Clinical Trials, Drugs, design, Médicaments, Ouvrages de vulgarisation, Développement, Études cliniques, Industrie pharmaceutique, Consommateurs, Éducation, Clinical Trials as TopicPlaces
United States| Edition | Availability |
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The new medicines: how drugs are created, approved, marketed, and sold
2006, Praeger Publishers, Praeger
in English
027598141X 9780275981419
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Book Details
Table of 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.
Edition Notes
Includes bibliographical references and index.
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| December 30, 2022 | Edited by MARC Bot | import existing book |
| September 16, 2021 | Edited by ImportBot | import existing book |
| December 11, 2020 | Edited by MARC Bot | import existing book |
| December 5, 2010 | Edited by Open Library Bot | Added subjects from MARC records. |
| December 10, 2009 | Created by WorkBot | add works page |