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The Resource New drug development : a regulatory overview, by Mark Mathieu ; with contributions from Christopher-Paul Milne

New drug development : a regulatory overview, by Mark Mathieu ; with contributions from Christopher-Paul Milne

Label
New drug development : a regulatory overview
Title
New drug development
Title remainder
a regulatory overview
Statement of responsibility
by Mark Mathieu ; with contributions from Christopher-Paul Milne
Creator
Contributor
Subject
Language
eng
Cataloging source
BTCTA
Illustrations
illustrations
Index
no index present
LC call number
RA401.A3
LC item number
M38 2008
Literary form
non fiction
Nature of contents
bibliography
New drug development : a regulatory overview, by Mark Mathieu ; with contributions from Christopher-Paul Milne
Label
New drug development : a regulatory overview, by Mark Mathieu ; with contributions from Christopher-Paul Milne
Publication
Related Contributor
Related Location
Related Agents
Related Authorities
Related Subjects
Bibliography note
Includes bibliographical references
Contents
An introduction to the U.S. new drug approval process -- Nonclinical drug testing -- The IND -- CDER and the IND review process -- The clinical development of new drugs -- Good clinical practice (GCP) -- The new drug application (NDA) -- The NDA review process -- The FDA's priority review policy -- Advisory committees and the drug approval process -- Beyond approval: postmarketing drug manufacturer regulatory responsibilities -- The supplemental NDA and postapproval changes to marketed drugs -- The FDA's orphan drug development program -- CDER's bioresearch monitoring program -- Accelerated drug approval/expanded access programs -- The pediatric studies initiative
http://library.link/vocab/cover_art
https://contentcafe2.btol.com/ContentCafe/Jacket.aspx?Return=1&Type=S&Value=9781882615858&userID=ebsco-test&password=ebsco-test
Dimensions
28 cm.
http://library.link/vocab/discovery_link
{'f': 'http://opac.lib.rpi.edu/record=b3148423'}
Edition
Rev. 8th ed.
Extent
362 p.
Isbn
9781882615858
Other physical details
ill.
System control number
(OCoLC)192081375

Library Locations

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