The new medicines
Subtitle: how drugs are created, approved, marketed, and sold
By: Bernice Schacter.
Publisher: Praeger Publishers; Praeger
Published: 2006
Place of publication: Westport, Conn
Language: eng
Number of pages: 267
Subjects: Drug development -- Popular works; Clinical trials -- Popular works; Pharmaceutical industry -- Popular works; Consumer education; Drug Industry -- organization & administration -- United States; Pharmaceutical Preparations -- economics -- United States; Clinical Trials -- United States; Drug Design -- United States; Drugs, Investigational -- economics -- United States; Legislation, Drug -- United States
Genres: Popular works.
Notes: Includes bibliographical references and index.
Table of contents: title: The path from bench to bedside; title: How did the FDA get to be in charge? The history of regulation of human drugs; title: The eureka moment: how new medicines are discovered; title: Test tube results are not enough: animal tests for a drug's utility; title: The business decisions: committing to development; title: Production of the new drug; title: Laboratory and animal safety testing; title: Getting set for clinical trials; title: Phase 1 clinical trials; title: Phase 2 clinical testing; title: Phase 3 testing; title: Putting together the application for approval: the new drug application (NDA); title: Now everybody holds their breath (and some people may brush up on the rules for insider trading), will the FDA file the NDA?; title: The FDA review; title: What do outside experts think? The advisory committee meeting and FDA approval; title: The launch-marketing the drug; title: It's not over till it's over: post approval studies; title: Are we (well) served? Do we have the system of industry and regulations we need want and may deserve.