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2005•Unpublished venueRequires access

The Role of Pharmacogenetics/Pharmacogenomics in Drug Development and Regulatory Review: Current Status

Shiew‐Mei Huang, Lawrence J. Lesko

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Abstract

This chapter contains sections titled: Introduction Variability in Drug Response Drug-metabolizing Enzymes and Transporters Applications of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review Determination of Different Genotype Groups based on Known Valid and Probable Valid Biomarkers Drug Interactions Voluntary versus Required Submissions Labeling Implications Conclusion

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What this paper is about

This chapter contains sections titled: Introduction Variability in Drug Response Drug-metabolizing Enzymes and Transporters Applications of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review Determination of Different Genotype Groups based on Known Valid and Probable Valid Biomarkers Drug Interactions Voluntary versus Required Submissions Labeling Implications Conclusion

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OpenAlex reports 2 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available abstract

This chapter contains sections titled: Introduction Variability in Drug Response Drug-metabolizing Enzymes and Transporters Applications of Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Review Determination of Different Genotype Groups based on Known Valid and Probable Valid Biomarkers Drug Interactions Voluntary versus Required Submissions Labeling Implications Conclusion

Key concepts: Pharmacogenomics, Pharmacogenetics, Drug response, Drug, Drug development, Pharmacology, Computational biology, Genotype

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