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New Drug Development

An Introduction to Clinical Trials: Second Edition

  • J. Rick┬áTurner

Table of contents

  1. Front Matter
    Pages i-xxv
  2. J. Rick Turner
    Pages 1-10
  3. J. Rick Turner
    Pages 11-20
  4. J. Rick Turner
    Pages 21-34
  5. J. Rick Turner
    Pages 35-46
  6. J. Rick Turner
    Pages 47-67
  7. J. Rick Turner
    Pages 99-114
  8. J. Rick Turner
    Pages 115-133
  9. J. Rick Turner
    Pages 135-141
  10. J. Rick Turner
    Pages 143-151
  11. J. Rick Turner
    Pages 153-164
  12. J. Rick Turner
    Pages 165-193
  13. J. Rick Turner
    Pages 195-210
  14. J. Rick Turner
    Pages 221-231
  15. J. Rick Turner
    Pages 233-245
  16. Back Matter
    Pages 247-256

About this book

Introduction

New Drug Development, 2nd Edition, is a reader-friendly introduction to clinical trials that is written specifically for entry-level professionals in the pharmaceutical, biopharmaceutical, and contract research organization (CRO) industries. It is also excellent reading for seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate fields of expertise, and for students of clinical research, pharmacy, medicine, nursing, and allied health professions. While the main focus is on preapproval clinical trials, the book adopts a lifecycle drug development approach, placing these trials in the overall continuum from drug discovery to postmarketing surveillance. It therefore contains brief discussions of medicinal chemistry, nonclinical research, drug manufacturing, and the latest techniques for gathering information concerning adverse drug reactions. This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development. The chapters dealing with the design and analysis of clinical trials in the first edition received praise from many sources. This new edition incorporates extended discussions of the operational aspects of conducting various kinds of trials, ranging from highly specialized and relatively small cardiac safety studies to very large, multi-site Phase III trials run in several different countries.

Keywords

Clinical Development Drug Introduction Trial Turner methodology

Authors and affiliations

  • J. Rick┬áTurner
    • 1
  1. 1.Cardiac Safety ServicesQuintilesDurhamUSA

Bibliographic information