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Early Phase Drug Evaluation in Man

  • Textbook
  • © 1990

Overview

Editors:
  1. John O’Grady

    1. May and Baker Pharmaceuticals Rhône-Poulenc Ltd, Dagenham, UK
      University of Vienna, Austria

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    You can also search for this editor in PubMed   Google Scholar

  2. Otto I. Linet

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

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    You can also search for this editor in PubMed   Google Scholar

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Table of contents (52 chapters)

  1. Front Matter

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

    1. Front Matter

      Pages 1-1
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    2. The Pharmaceutical Background

      • Shri C. Valvani
      Pages 3-13

    3. The Pharmacological Background

      • B. J. R. Whittle, J. A. Salmon, R. M. Ferris
      Pages 14-24

    4. The Metabolic Background

      • Wade J. Adams
      Pages 25-38

    5. The Toxicological Background

      • Anthony Dayan
      Pages 39-62

    6. Animal Tests as Predictors of Human Response

      • Peter I. Folb
      Pages 63-82

    7. International Regulatory Requirements

      • F. W. Teather
      Pages 83-88

    8. Regulatory Requirements in Japan

      • Yasushi Yoshino
      Pages 89-96

  3. Organisation and Decision Making

    1. Front Matter

      Pages 97-97
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    2. The Organisation of New Drug Evaluation in the Pharmaceutical Industry

      • Yves Champey
      Pages 99-109

    3. The Role of Contract Research Units

      • A. P. Fletcher
      Pages 110-120

    4. Decision Points in Human Drug Development

      • Richard D. Mamelok, Jan Lessem
      Pages 121-126

    5. Good Clinical Research Practice and Quality Assurance

      • Brian Gennery
      Pages 127-135

  4. Ethical and Legal Considerations

    1. Front Matter

      Pages 137-137
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    2. Ethical Aspects of Research in Healthy Volunteers

      • Steven J. Warrington
      Pages 139-149

    3. Ethical Aspects of Research in Patients

      • Frank Wells
      Pages 150-160

    4. Legal Liabilities in Clinical Trials

      • Ian C. Dodds-Smith
      Pages 161-191

  5. Measuring Drug Activity in Man

    1. Front Matter

      Pages 193-193
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    2. The Assessment of Tolerance and Side-effects in Non-patient Volunteers

      • Derrick Jackson
      Pages 195-205
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Keywords

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

  • Book Title: Early Phase Drug Evaluation in Man

  • Editors: John O’Grady, Otto I. Linet

  • DOI: https://doi.org/10.1007/978-1-349-10705-6

  • Publisher: Red Globe Press London

  • eBook Packages: Engineering, Engineering (R0)

  • Copyright Information: Macmillan Publishers Limited 1990

  • Edition Number: 1

  • Number of Pages: X, 737

  • Additional Information: Previously published under the imprint Palgrave

  • Topics: Pharmacology/Toxicology, Pharmacy

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