Early Phase Drug Evaluation in Man

  • John O’Grady
  • Otto I. Linet
Book

Table of contents

  1. Front Matter
    Pages i-x
  2. Preliminaries to Testing of Drugs in Man

    1. Front Matter
      Pages 1-1
    2. Shri C. Valvani
      Pages 3-13
    3. B. J. R. Whittle, J. A. Salmon, R. M. Ferris
      Pages 14-24
    4. Wade J. Adams
      Pages 25-38
    5. Anthony Dayan
      Pages 39-62
    6. F. W. Teather
      Pages 83-88
    7. Yasushi Yoshino
      Pages 89-96
  3. Organisation and Decision Making

    1. Front Matter
      Pages 97-97
    2. A. P. Fletcher
      Pages 110-120
    3. Richard D. Mamelok, Jan Lessem
      Pages 121-126
  4. Ethical and Legal Considerations

    1. Front Matter
      Pages 137-137
    2. Steven J. Warrington
      Pages 139-149
    3. Frank Wells
      Pages 150-160
    4. Ian C. Dodds-Smith
      Pages 161-191
  5. Measuring Drug Activity in Man

    1. Front Matter
      Pages 193-193

About this book

Introduction

This book is a practical detailed and comprehensive guide for those involved in the conduct of early human studies with new drugs. It covers the pre-clinical information relevant to first human studies including pharmaceutical, metabolic, toxicological and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors are drawn internationally both from the pharmaceutical industry and academia. The book provides a unique practical guide to all concerned with the development of new drugs.

Keywords

cardiovascular system drug kidney pharmaceutical pharmaceutical industry research

Editors and affiliations

  • John O’Grady
    • 1
    • 2
  • Otto I. Linet
    • 3
  1. 1.May and Baker Pharmaceuticals Rhône-Poulenc LtdDagenhamUK
  2. 2.University of ViennaAustria
  3. 3.Clinical Development Unit 1The Upjohn CompanyKalamazooUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-349-10705-6
  • Copyright Information Macmillan Publishers Limited 1990
  • Publisher Name Palgrave, London
  • eBook Packages Engineering
  • Print ISBN 978-1-349-10707-0
  • Online ISBN 978-1-349-10705-6
  • About this book
Industry Sectors
Chemical Manufacturing
Biotechnology
Consumer Packaged Goods
Pharma