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New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) - Mark Mathieu
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Mark Mathieu:

New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) - hardcover

2008, ISBN: 1882615859

[SR: 918613], Hardcover, [EAN: 9781882615858], Parexel Intl Corp, Parexel Intl Corp, Book, [PU: Parexel Intl Corp], Parexel Intl Corp, Go inside the drug development and FDA regulatory pr… More...

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New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) - Mark Mathieu
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Mark Mathieu:

New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) - hardcover

2008, ISBN: 1882615859

[SR: 918613], Hardcover, [EAN: 9781882615858], Parexel Intl Corp, Parexel Intl Corp, Book, [PU: Parexel Intl Corp], Parexel Intl Corp, Go inside the drug development and FDA regulatory pr… More...

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New Drug Development: A Regulatory Overview - Mathieu, Mark P.
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Mathieu, Mark P.:
New Drug Development: A Regulatory Overview - hardcover

2008

ISBN: 9781882615858

Mitwirkende: Milne, Christopher-Paul, Parexel International Corporation, Gebundene Ausgabe, Auflage: Revised, 362 Seiten, Publiziert: 2008-01-01T00:00:01Z, Produktgruppe: Buch, 1.22 kg, P… More...

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New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) - Mark Mathieu
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Mark Mathieu:
New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) - hardcover

2008, ISBN: 1882615859

[EAN: 9781882615858], New book, [SC: 16.44], [PU: Parexel Intl Corp], Brand New!, Books

NEW BOOK. Shipping costs: EUR 16.44 Save With Sam, North Miami, FL, U.S.A. [65537386] [Rating: 5 (of 5)]
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New Drug Development - Mark Mathieu (author), Christopher-Paul Milne (contributions)
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Mark Mathieu (author), Christopher-Paul Milne (contributions):
New Drug Development - hardcover

ISBN: 9781882615858

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Details of the book
New Drug Development: A Regulatory Overview

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:

* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.

* How the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes.

* How CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process.

* How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.

* Which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.


Find out why New Drug Development is pharma/biotech's go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.

Details of the book - New Drug Development: A Regulatory Overview


EAN (ISBN-13): 9781882615858
ISBN (ISBN-10): 1882615859
Hardcover
Publishing year: 2008
Publisher: Parexel International Corporation
362 Pages
Weight: 1,260 kg
Language: eng/Englisch

Book in our database since 2009-02-24T13:23:34+00:00 (London)
Detail page last modified on 2023-11-01T06:39:46+00:00 (London)
ISBN/EAN: 1882615859

ISBN - alternate spelling:
1-882615-85-9, 978-1-882615-85-8
Alternate spelling and related search-keywords:
Book author: mark mathieu, christopher milne
Book title: mathieu, new drug development


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Latest similar book:
9780931283062 New drug development: A regulatory overview (Mark P. (editor) Mathieu)


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