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The Organisation of New Drug Evaluation in the Pharmaceutical Industry

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Early Phase Drug Evaluation in Man

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Abstract

The pharmaceutical industry manufactures a consumer product: the drug. The production and sale of this consumer product are strictly regulated. There are, however, no such regulations governing research and development, with the exception of a few rules covering the methodology of toxicological studies and, in some countries, the methodology of clinical studies. Rules are, nevertheless, imposed upon the industrial researcher, and these are contained within two coexisting frames of reference which are a factor in all decision making. These frames of reference are those of medicine and of industry.

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Bibliography

  • Booth, C. C. (1985). Clinical research today. Trans. Med. Soc. Lond., 102, 24–41

    PubMed  Google Scholar 

  • Feinstein, A. R. (1984). Current problems and future challenges in randomized clinical trials. Circulation, 70 (5), 761–14

    Article  Google Scholar 

  • IFPMA (1986). The impact of product registration. In Symposium on Scientific Innovation in Drug Development. IFPMA, Geneva

    Google Scholar 

  • Meinert, C. L. (1988). Toward prospective registration of clinical trials. Controlled Clin. Trials, 9 (1), 1–5

    Article  CAS  PubMed  Google Scholar 

  • Pinto, O. de S. (1986). Organisation and problems of drug evaluation in multicentre clinical trials. Br. J. Clin. Pharmacol., 22, suppl., 49S–53S

    Article  Google Scholar 

  • Rauch, L., Kranzler, J. and Chivis, A. Jr. (1988). The many faces of discovery: a managers’ guide to research. Pharmaceutical Executive, April

    Google Scholar 

  • Taylor, K. M., Shapiro, M. and Skinner, H. A. (1987). Some thoughts on the future of clinical trials groups in cancer [letter]. Cancer Treat. Rep., 71 (4), 434–5

    CAS  PubMed  Google Scholar 

  • Walker, B. C. and Walker, S. R. (1986). Trends and changes in drug research and development. Proc. Soc. Drug Res., London, 26/09/1986, Kluwer Acad. Pub., London

    Google Scholar 

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Author information

Authors and Affiliations

  1. Medical and Scientific Development, Rhône-Poulenc Santé, 20 Avenue Raymond Aron, Antony Cedex, 92165, France

    Yves Champey (Vice President)

Authors
  1. Yves Champey
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Editor information

Editors and Affiliations

  1. May and Baker Pharmaceuticals Rhône-Poulenc Ltd, Dagenham, RM10 7XS, UK

    John O’Grady MD, FRCP (Medical Director, Visiting Professor of Clinical Pharmacology) (Medical Director, Visiting Professor of Clinical Pharmacology)

  2. University of Vienna, Austria

    John O’Grady MD, FRCP (Medical Director, Visiting Professor of Clinical Pharmacology) (Medical Director, Visiting Professor of Clinical Pharmacology)

  3. Clinical Development Unit 1, The Upjohn Company, Kalamazoo, MI, 49001, USA

    Otto I. Linet MD, PhD (Director) (Director)

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© 1990 The editors and contributors

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Champey, Y. (1990). The Organisation of New Drug Evaluation in the Pharmaceutical Industry. In: O’Grady, J., Linet, O.I. (eds) Early Phase Drug Evaluation in Man. Palgrave, London. https://doi.org/10.1007/978-1-349-10705-6_8

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  • DOI: https://doi.org/10.1007/978-1-349-10705-6_8

  • Publisher Name: Palgrave, London

  • Print ISBN: 978-1-349-10707-0

  • Online ISBN: 978-1-349-10705-6

  • eBook Packages: EngineeringEngineering (R0)

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