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• W2495881489 abstract "PGx/biomarkers have been recognized as the useful tools in drug development. They have substantially contributed to increased efficiency in drug development, which has resulted in major advances in personalized medicine as novel targeted drugs are being successfully developed for use in several therapeutic areas, including oncology. Because the application of PGx/biomarkers in drug development can reveal a drug’s dose and target population more accurately than other conventional approaches, in the last decade more and more drugs have included PGx/biomarker information in their labels. In this chapter, we describe the current regulatory guidelines on PGx/biomarkers and their qualification by regulatory agencies in different ICH regions. We also describe the design of clinical trials utilizing a PGx/biomarkers for drug development, and we discuss the future challenges on these new tools." @default.
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• W2495881489 date "2014-01-01" @default.
• W2495881489 modified "2023-09-23" @default.
• W2495881489 title "PGx/Biomarker Utilization for Regulatory Decision Making" @default.
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• W2495881489 doi "https://doi.org/10.1016/b978-0-12-386882-4.00042-6" @default.
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