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
    2. J. D. Harry
      Pages 220-228
    3. Stephen Toon
      Pages 229-242
    4. J. McEwen, Ian H. Stevenson
      Pages 243-250
  6. Assessment of Drug Effects on the Cardiovascular System

    1. Front Matter
      Pages 251-251
    2. Edmond Roland
      Pages 265-287
    3. Pran K. Marrott
      Pages 288-301
    4. John R. Cockcroft, David J. Webb
      Pages 302-312
    5. Janet E. Rush, Mariell Jessup
      Pages 313-325
    6. J. Ritter
      Pages 326-336
    7. H. Sinzinger, P. Fitscha
      Pages 337-347
  7. Assessment of Drug Effects on the Respiratory System

    1. Front Matter
      Pages 349-349
    2. Timothy W. Evans, Peter J. Barnes
      Pages 351-361
    3. A. M. Edwards
      Pages 362-375
  8. Assessment of Drug Effects on the Central Nervous System

    1. Front Matter
      Pages 377-377
    2. B. Musch, I. Hindmarch, B. Saletu
      Pages 379-394
    3. J. I. Morrow, A. Richens
      Pages 395-406
    4. B. Musch
      Pages 407-420
    5. G. R. McClelland, P. J. Summerfield
      Pages 421-432
    6. Judith L. Siegel, Zofia E. Dziewanowska, Harriet Laine
      Pages 433-442
    7. T. H. Corn, J. R. M. Haigh
      Pages 443-453
  9. Assessment of Drug Effects on the Gastrointestinal System

    1. Front Matter
      Pages 455-455
    2. K. H. Antonin, P. R. Bieck
      Pages 457-480
    3. Colin Broom
      Pages 481-491
  10. Assessment of Drug Effects on the Kidney

    1. Front Matter
      Pages 493-493
    2. J. McMurray, J. McEwen
      Pages 495-507
    3. Anne Dawnay
      Pages 508-517
  11. Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology

    1. Front Matter
      Pages 519-519

About this book


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.


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