Evaluation of Characteristics and Ethnic Sensitivity for FDA‐Approved Drugs with Racial and Ethnic Differences in Pharmacokinetics, Safety, and Efficacy

Abstract excerpt

Racial and ethnic differences in drug disposition and response may have a significant impact on its risk-benefit balance. Therefore, it is important to examine whether an investigational drug has characteristics that make the pharmacokinetics (PK), safety, and efficacy likely to be affected by intrinsic and extrinsic ethnic factors based on ethnic sensitivity assessment. This assessment is recommended by the...

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