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Regulatory aspects of integration of pharmacogenetics into drug development

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References

  1. CPMP Guidance on ‘Pharmacokinetic Studies in Man’ (Eudra/C/87/013) In: ‘The Rules Governing Medicinal Products in the European Union’ EudraLex, Vol 3C ‘Guidelines — Efficacy’, Luxembourg: Office for Official Publications of the European Communities; 1998, p. 99.

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  2. ICH Topic E4 Step 5. ‘Note for Guidance on Dose Response information to support drug registration’. CPMP/ICH/378/95 — May 1995.

  3. CPMP ‘Note for Guidance on the Investigation of Drug Interactions’. CPMP/ EWP/560/95 — December 1997.

  4. CPMP ‘Draft Note for Guidance on Dose Response information of Bioavailability and Bioequivalence’. CPMP/EWP/QWP/1401/98 December 2000.

  5. ICH Topic E5-Step 5. ‘Note for Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data’. CPMP/ICH/289/95 — November 1994.

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Acknowledgments

This paper has also been published recently in Pharmaceutical News 2000;7:32–38. The author wishes to thank the publishers of Pharmaceutical News for their permission to reproduce this paper in a modified form.

The views expressed in this paper are those of the author and do not necessarily represent the views or the opinions of the Medicines Control Agency, other regulatory authorities or any of their advisory committees.

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Authors and Affiliations

  1. Pharmacogenetics Working party, Regulatory Sub-group, UK

    Rashmi R. Shah

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  1. Rashmi R. Shah
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Shah, R.R. Regulatory aspects of integration of pharmacogenetics into drug development. International Journal of Pharmaceutical Medicine 15, 67–69 (2001). https://doi.org/10.1097/00124363-200104000-00007

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