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Early Phase Drug Evaluation in Man pp 89–96Cite as

Regulatory Requirements in Japan

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Abstract

The Phase I clinical trial is the first clinical trial in which a drug is administered to human subjects. Accordingly, the most important aspect of carrying out the Phase I clinical trial is to ensure the safety of the human subjects. There are various views concerning the scope of animal tests to be performed before the start of Phase I clinical trials and decisions in this respect are important to doctors and drug manufacturers who perform them. Of course, biological differences between humans and animals must be taken into account when pharmaceuticals are being developed.

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Author information

Authors and Affiliations

  1. Production Registration Group, Upjohn Pharmaceuticals Ltd, 17F Shinjuku Green Tower Building, 14-1 Nishi-Shinjuku 6-chome, Tokyo, 160, Japan

    Yasushi Yoshino (Head)

Authors
  1. Yasushi Yoshino
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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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Yoshino, Y. (1990). Regulatory Requirements in Japan. 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_7

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  • DOI: https://doi.org/10.1007/978-1-349-10705-6_7

  • 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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