The Impact of Genetic Differentiation Across Regions: The Case of Drug Responses and Clinical Trials
Genetic differentiation across regions can significantly impact how populations respond to drugs. Variations in genetic makeup mean that a medication might be effective for one group but less so, or even harmful, for another. This variability underscores the importance of tailored clinical trials and has implications for the recent CDSCO notification on waiving clinical trials. Here, we’ll explore examples where genetic differences have influenced drug efficacy and safety, highlighting the importance of considering these differences in drug approval processes. Warfarin and Genetic Variability Case Study: Warfarin is a widely used anticoagulant prescribed to prevent blood clots. The drug's dosing is highly individualized, and genetic variations play a crucial role in how patients metabolize it. Variants in the CYP2C19 gene and the VKORC1 gene influence Warfarin’s effectiveness and risk of bleeding. Genetic Differentiation:In populations of European descent, certain genetic variants