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  • Textbook
  • © 1990

Early Phase Drug Evaluation in Man

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Table of contents (52 chapters)

  1. Measuring Drug Activity in Man

    1. The Assessment of Pharmacodynamic Effects

      • J. D. Harry
      Pages 220-228
    2. The Assessment of Pharmacokinetics

      • Stephen Toon
      Pages 229-242
    3. Radiolabelled Metabolism Studies in Man

      • J. McEwen, Ian H. Stevenson
      Pages 243-250
  2. Assessment of Drug Effects on the Cardiovascular System

    1. Front Matter

      Pages 251-251
    2. Anti-anginal Drugs

      • Edmond Roland
      Pages 265-287
    3. Anti-arrhythmic Agents

      • Pran K. Marrott
      Pages 288-301
    4. Phase I Trials on Anti-hypertensive Drugs

      • John R. Cockcroft, David J. Webb
      Pages 302-312
    5. Drugs for Heart Failure

      • Janet E. Rush, Mariell Jessup
      Pages 313-325
    6. Antithrombotic and Thrombolytic Drugs

      • J. Ritter
      Pages 326-336
    7. Monitoring of Antithrombotic Activity by Platelet Labelling

      • H. Sinzinger, P. Fitscha
      Pages 337-347
  3. Assessment of Drug Effects on the Respiratory System

    1. Front Matter

      Pages 349-349
    2. Assessment of Respiratory Responses

      • Timothy W. Evans, Peter J. Barnes
      Pages 351-361
    3. Anti-asthmatic Drugs

      • A. M. Edwards
      Pages 362-375
  4. Assessment of Drug Effects on the Central Nervous System

    1. Front Matter

      Pages 377-377
    2. Measurement of CNS Effects

      • B. Musch, I. Hindmarch, B. Saletu
      Pages 379-394
    3. Drugs in Epilepsy

      • J. I. Morrow, A. Richens
      Pages 395-406
    4. Anxiolytics

      • B. Musch
      Pages 407-420

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.

Editors and Affiliations

  • May and Baker Pharmaceuticals Rhône-Poulenc Ltd, Dagenham, UK

    John O’Grady

  • University of Vienna, Austria

    John O’Grady

  • Clinical Development Unit 1, The Upjohn Company, Kalamazoo, USA

    Otto I. Linet

Bibliographic Information