The new medicines, how drugs are created, approved, marketed, and sold, Bernice Schacter
Type
Label
The new medicines, how drugs are created, approved, marketed, and sold, Bernice Schacter
Language
eng
Bibliography note
Includes bibliographical references (p. [237]-257) and index
Index
index present
Literary Form
non fiction
Main title
The new medicines
Nature of contents
bibliography
Oclc number
60839355
Responsibility statement
Bernice Schacter
Sub title
how drugs are created, approved, marketed, and sold
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