Impact of the Ich Guideline on Ethnic Differences

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This paper discusses the recent Step 2 document of the International Conference on Harmonization on ethnic factors in the acceptability of foreign clinical data and its possible impact on industry.

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Correspondence to Dr. Helene Dumitriu PhD.

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Dumitriu, H. Impact of the Ich Guideline on Ethnic Differences. Ther Innov Regul Sci 32, 141–144 (1998) doi:10.1177/009286159803200119

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Key Words

  • Ethnic differences
  • Foreign clinical data
  • Bridging studies