Ethnic Factors in the Acceptability of Foreign Clinical Data

@article{Naito1998EthnicFI,
  title={Ethnic Factors in the Acceptability of Foreign Clinical Data},
  author={Chikayuki Naito},
  journal={Therapeutic Innovation & Regulatory Science},
  year={1998},
  volume={32},
  pages={1283S - 1292S}
}
In the 1980s, Japan, the European Union, and the United States enacted separate regulations to increase the acceptability of foreign data in support of pharmaceutical drug approval. In the 1990s, the International Conference on Harmonization (ICH) began work on harmonizing these regulations through the E5 Expert Working Group. This paper discusses the concept and purpose of the ICH, ethnic factors which influence mutual acceptance of foreign clinical data, and the final harmonized document… CONTINUE READING

Topics from this paper.

Citations

Publications citing this paper.
SHOWING 1-10 OF 20 CITATIONS

Sample Size Calculations in Clinical Research

VIEW 9 EXCERPTS
CITES BACKGROUND & METHODS
HIGHLY INFLUENCED

Japan and Taiwan in the wake of bio-globalization : drugs, race and standards

VIEW 9 EXCERPTS
CITES METHODS & BACKGROUND
HIGHLY INFLUENCED

References

Publications referenced by this paper.
SHOWING 1-10 OF 10 REFERENCES

Relevance of Ethnic Factors in Global Development

C. Naito
  • Historical Overview. In: D’Arcy PF, Harron DWG, eds. Proceedings of The Fourth International Conference on Harmonisation, Brussels
  • 1997

ICH-2 E5-Expert Working Group Report. Ethnic factors to be considered in the acceptability of foreign clinical data

M ChikuyukiNaitoWeintraub, RL Williams
  • J Clin Therap & Med
  • 1995

Arcy PF, H m n DWG

D In
  • Pmceedings of The Second International Conference on Harmonisation,
  • 1993

Which is more important in pharmacokinetics: Interethnic or intraethnic variability

H. Yasuhara
  • Harron DWG, eds. Proceedings of The Second International Conference on Harmonisation,
  • 1993

Introduction to Study on Clinical Medicine, Methodology and Ethics

S. Sunahara
  • Igaku-Shoin;
  • 1988

Ethnic factors in the acceptability of foreign data : Rapporteur ’ s introduction

C Naito

    Ethnic factors to be considered in the acceptability of foreign clinical data

    RL Williams

      Rapporteur ’ s report

      C Naito

        Relevance of Ethnic Factors in Global Development . Historical Overview

        C Naito