1. A Framework for Evidence-Based Clinical Practice

Author(s):  Wendy L. HurleyCraig R. DenegarJay Hertel

Publisher: Wolters Kluwer/Lippincott Williams & Wilkins

Year: 2011

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2. Designing clinical research, 4th Edition

Author(s):  Dr. Stephen B Hulley MD MPH, Steven R Cummings MD, Warren S Browner MD MPH, Deborah G Grady MD MPH, Thomas B Newman MD MPH

Publisher: Lippincott Williams & Wilkins

Year: 2013

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3. Drugs: From Discovery to Approval, 3rd Edition

Author(s):  Rick Ng

Publisher: Wiley-Blackwell

Year: 2015

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4. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics, 2nd Edition

Author(s):  Douglas J. Pisano, David S. Mantus

Publisher: Informa Healthcare USA

Year: 2008

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5. Foundations of Clinical Research- Applications to Practice, 3rd Edition

Author(s):  Leslie G. Portney DPT Ph.D. FAPTA, Mary P. Watkins DPT MS

Publisher: F.A. Davis Company

Year: 2015

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6. Guidebook for Drug Regulatory Submissions, 1st Edition

Author(s):  Sandy Weinberg

Publisher: Wiley

Year: 2009

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7. New Drug Approval Process -Accelerating Global Registrations, 4th Edition

Author(s):  Richard A. Guarino, Richard Guarino

Publisher: CRC Press

Year: 2004

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8. Principles and Practice of Clinical Research, 3rd Edition

Author(s): John I. GallinFrederick P OgnibeneLaura Lee Johnson

Publisher: Academic Press

Year: 2012

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9. Principles of Research Methodology- A Guide for Clinical Investigators

Author(s):  Phyllis G. Supino EdD (auth.), Phyllis G. Supino, Jeffrey S. Borer

Publisher: Springer-Verlag New York

Year: 2012

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10. The Pharmaceutical Regulatory Process, 2nd Edition

Author(s):  R. Berry Ira, Robert P. Martin

Publisher: Informa Healthcare

Year: 2008

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11. Textbook of Clinical Trials, 2nd Edition

Author(s):  David MachinSimon DaySylvan Green

Publisher: John Wiley & Sons

Year: 2007

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