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New drug development : a regulatory overview

Author: Mark P Mathieu; Ronald Keeney; Christopher-Paul Milne; Parexel International Corporation.
Publisher: Waltham, MA : PAREXEL International Corp., ©2002.
Edition/Format:   Print book : English : 6th edView all editions and formats
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Additional Physical Format: Online version:
Mathieu, Mark P.
New drug development.
Waltham, MA : PAREXEL International Corp., ©2002
(OCoLC)606973707
Document Type: Book
All Authors / Contributors: Mark P Mathieu; Ronald Keeney; Christopher-Paul Milne; Parexel International Corporation.
ISBN: 1882615425 9781882615421
OCLC Number: 50182731
Description: 327 pages : illustrations ; 28 cm
Contents: An introduction to the U.S. new drug approval process --Nonclinical drug testing --
The investigational new drug application --
CDER and the IND review process --
The clinical development of new drugs --
Good clinical practices (GCP) --
The new drug application --
The NDA review process --
The FDA's priority review policy --
Advisory committees and the drug approval process --
Beyond approval: 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.
Responsibility: by Mark Mathieu ; with contributions from Ronald Keeney and Christopher-Paul Milne.

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