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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences)
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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences) - hardcover

2008, ISBN: 9780849391842

Editor: Hynes, Martin D. CRC Press, Hardcover, Auflage: 2, 304 Seiten, Publiziert: 2008-03-05T00:00:01Z, Produktgruppe: Book, 0.54 kg, Verkaufsrang: 5684473, Textbook Rental ASINs, Specia… More...

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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences, Band 181)
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Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences, Band 181) - hardcover

2008, ISBN: 9780849391842

CRC Press Inc, Gebundene Ausgabe, Auflage: 2, 278 Seiten, Publiziert: 2008-03-06T00:00:01Z, Produktgruppe: Buch, 1.2 kg, Pharmakologie, Medizin, Kategorien, Bücher, Risikomanagement, Kost… More...

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Hynes, Martin D.:
Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences) - hardcover

2008

ISBN: 0849391849

[EAN: 9780849391842], Gebraucht, sehr guter Zustand, [PU: CRC Press], Light rubbing wear to cover, spine and page edges. Very minimal writing or notations in margins not affecting the tex… More...

NOT NEW BOOK. Shipping costs: EUR 8.37 Discover Books, Toledo, OH, U.S.A. [64434602] [Rating: 5 (von 5)]
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Brittain H.G.,Deb,Deb A.K,Ebadi M.,Graebel,Graebel W. P,Hynes M.D.,Kalacska,Kalacska M.,Lelieveld H.L.M,Lewis,Rossell J.B,Salunkhe D.K.,Seethala R.,Signore A.A.,Silverman,Silverman R. B,Thassu D.,Vasic,Vasic B.,Whitaker,Zeng,Zeng X.M:
Pharmaceutical Pre-Approval Inspections, 2/E, Vol.181 (Ex): A Guide To Regulatory Success - new book

2008, ISBN: 9780849391842

Taylor & Francis, 2008. New., Taylor & Francis, 2008, 6

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Hynes, Martin D. (Editor):
Preparing for Fda Pre-Approval Inspections: a Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences) - hardcover

2008, ISBN: 9780849391842

hardcover, Neubuch, [PU: CRC Press]

Shipping costs:plus shipping costs Newport Coast, CA, Tustin

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Details of the book
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences, Band 181)

This Second Edition is an essential guide to preparing for FDA pre-approval inspections taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval. Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition: chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility

Details of the book - Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success: A Guide to Regulatory Success, Second Edition (Drugs and the Pharmaceutical Sciences, Band 181)


EAN (ISBN-13): 9780849391842
ISBN (ISBN-10): 0849391849
Hardcover
Publishing year: 2008
Publisher: Hynes, Martin D., III, CRC Press Inc
278 Pages
Weight: 0,540 kg
Language: eng/Englisch

Book in our database since 2010-11-22T11:05:45-05:00 (New York)
Detail page last modified on 2023-06-11T02:30:25-04:00 (New York)
ISBN/EAN: 9780849391842

ISBN - alternate spelling:
0-8493-9184-9, 978-0-8493-9184-2
Alternate spelling and related search-keywords:
Book author: martin


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