Article
Ethnic Bridging of Sepiapterin in Chinese and Korean Populations Based on Predictions From Genetic Polymorphism of Breast Cancer Resistance Protein.
Clinical and translational science - 1 Apr 2026
Gao Lan, Smith Neil, Kong Ronald
Abstract excerpt
Ethnic differences are crucial when considering the efficacy, safety, and dose of pharmaceuticals across diverse populations. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline E5 addresses the acceptability of extrapolating foreign clinical data taking ethnic factors into consideration. Sepiapterin has recently been approved for the treatment...
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