An edition of The new medicines (2006)

The new medicines

how drugs are created, approved, marketed, and sold

by

Cover of: The new medicines by Bernice Zeldin Schacter, Bernice Zeldin Schacter
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Last edited by MARC Bot
March 7, 2023 | History
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An edition of The new medicines (2006)

The new medicines

how drugs are created, approved, marketed, and sold

by

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Publish Date
Publisher
Praeger Publishers, Praeger
Language
English
Pages
267

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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 Topic

Places

United States
Edition Availability
Cover of: The new medicines
The new medicines: how drugs are created, approved, marketed, and sold
2006, Praeger Publishers, Praeger
in English

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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.

Published in
Westport, Conn
Genre
Popular works.

Classifications

Dewey Decimal Class
615/.19
Library of Congress
RM301.25 .S34 2006, RM301

The Physical Object

Pagination
p. ;
Number of pages
267

ID Numbers

Open Library
OL3403932M
Internet Archive
newmedicineshowd00scha
ISBN 10
027598141X
LCCN
2005019187
OCLC/WorldCat
60839355
Library Thing
1251791
Amazon ID (ASIN)
Goodreads
2628523

Source records

Scriblio MARC record
Ithaca College Library MARC record
Internet Archive item record
Library of Congress MARC record
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History

Download catalog record: RDF / JSON / OPDS | Wikipedia citation
March 7, 2023 Edited by MARC Bot import existing book
December 30, 2022 Edited by MARC Bot import existing book
December 10, 2022 Edited by ImportBot import existing book
September 16, 2021 Edited by ImportBot import existing book
April 1, 2008 Created by an anonymous user Imported from Scriblio MARC record