Skip to main content
Log in

Impact of the Ich Guideline on Ethnic Differences

  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

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 via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

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

    Article  CAS  Google Scholar 

  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.

    Google Scholar 

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

    Article  Google Scholar 

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

    Article  CAS  Google Scholar 

  5. Scrip Daily News. S00420768 of October 20, 1994.

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

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

    CAS  PubMed  Google Scholar 

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

    Article  Google Scholar 

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

    CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

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). https://doi.org/10.1177/009286159803200119

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286159803200119

Key Words

Navigation