Chapter 4. Exploratory Development

  1. John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
  2. John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
  1. John Posner

Published Online: 25 OCT 2007

DOI: 10.1002/9780470987391.ch4

Book Title

The Textbook of Pharmaceutical Medicine, Fifth Edition

The Textbook of Pharmaceutical Medicine, Fifth Edition

Additional Information

How to Cite

Posner, J. (2007) Exploratory Development, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch4

Editor Information

  1. 1

    Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London

  2. 2

    Visiting Professor of Clinical Pharmacology, University of London

Publication History

  1. Published Online: 25 OCT 2007
  2. Published Print: 15 DEC 2005

ISBN Information

Print ISBN: 9780727918406

Online ISBN: 9780470987391

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CHAPTER TOOLS

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Keywords:

  • drug development;
  • new molecular entity;
  • pharmacokinetics;
  • minimum acceptable profile;
  • pharmacodynamics

Summary

This chapter contains sections titled:

  • Introduction

  • Planning ED

  • Requirements for Administration of a NME to Humans

  • Preparation for the first administration to man

  • Studies in Healthy Volunteers

  • Study Objectives in ED

  • Design of the First Study in Humans

  • Minimising Risk

  • Subsequent Studies in Healthy Volunteers

  • Studies in Patients

  • Outcomes of ED

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