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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success,
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Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition Hardcover - 2008

by Martin D. Hynes (Editor)


From the publisher

Rev. ed. of: Preparing for FDA pre-approval inspections. c1999. Includes bibliographical references and index.

Details

  • Title Preparing for FDA Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition
  • Author Martin D. Hynes (Editor)
  • Binding Hardcover
  • Edition INTERNATIONAL ED
  • Pages 304
  • Volumes 1
  • Language ENG
  • Publisher CRC Press
  • Date 2008
  • Illustrated Yes
  • Features Bibliography, Illustrated, Index, Table of Contents
  • ISBN 9780849391842 / 0849391849
  • Weight 1.19 lbs (0.54 kg)
  • Dimensions 9.25 x 6.43 x 0.8 in (23.50 x 16.33 x 2.03 cm)
  • Library of Congress subjects United States, Drug Approval - United States
  • Library of Congress Catalog Number 2007042240
  • Dewey Decimal Code 615.19

About the author

MARTIN D. HYNES III is Director of Product Research and Development and Six Sigma Champion at Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana. Dr. Hynes has authored or co-authored numerous scientific articles, abstracts, book chapters, books, and patents. He is a member of a number of scientific and industry organizations. He has spoken and served as session chair at meetings of these organizations on numerous occasions. Dr. Hynes earned his bachelor's degree in psychology from Providence College and his Ph.D. in pharmacology and toxicology from the University of Rhode Island. After completing a post-doctoral fellowship at the Roche Institute of Molecular Biology, he joined Lilly Research Labs. He has held several management positions, including Director of Pharmaceutical Project Management, Director of Quality Assurance, and Director for Clinical Research for Eli Lilly, Japan.

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