Advertisement

Impact of the Ich Guideline on Ethnic Differences

  • 1 Citations

Abstract

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.

This is a preview of subscription content, log in to check access.

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.

References

  1. 1.

    Larson E. Exclusion of certain groups from clinical research. Image - J Nursing Scholar. 1994;26(3):185–190.

  2. 2.

    Draft Consensus Guideline Ethnic Factors in the Acceptability of Foreign Clinical Data, Released for Consultation at Step 2 of the ICH Process on March 6, 1997 by the ICH Steering Committee.

  3. 3.

    Mathews HW. Racial, ethnic and gender differences in response to medicines. Drug Metabol Drug Interact. 1995;12(2):77–91.

  4. 4.

    Yasuhara H. Ethnic factors in evaluation of drug efficacy and safety. Folia Pharmacol JPN. 1994;104(2):67–78.

  5. 5.

    Scrip Daily News. S00420768 of October 20, 1994.

  6. 6.

    Scrip. No. 2046, July 24, 1995, p. 27.

  7. 7.

    Edwards NC. Important considerations in the use of ethnicity as a study variable. Canad J Public Health. 1992;83(1):31–33.

  8. 8.

    Balant LP, Welling PG. Interethnic factors important for drug development and registration. Clin Res Regul Affairs. 1995;12(1):23–46.

  9. 9.

    Crews DE, Bindon JR. Ethnicity as a taxonomic tool in biomedical and biosocial research. Ethnicity Disease. 1991;1(1):42–49.

Download references

Author information

Correspondence to Dr. Helene Dumitriu PhD.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

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

Download citation

Key Words

  • Ethnic differences
  • Foreign clinical data
  • Bridging studies