A comparison of the clinical evaluation of medicines in Japanese and Caucasian populations
In order to compare inter-and intra-ethnic variability in drug response, in Japanese and Caucasian subjects, the clinical data for five drugs has been reviewed, focusing on the pharmacokinetic parameters. These drugs represent different pharmacological/therapeutic classes.
No pharmacogenetically linked differences between Caucasian and Japanese subjects were found. With regard to pharmacokinetic parameters, for all five drugs the intra-ethnic variability was higher than the inter-ethnic variability.
Differences in methodology and the number of subjects studied might contribute to the apparent variations in pharmacokinetic parameters. In order to draw firm conclusions regarding inter-ethnic differences in drug response it will therefore be necessary to harmonise the principles and technical aspects of drug development methodology.
KeywordsPharmacokinetic Parameter Drug Response Japanese Subject Pharmacodynamic Data Ethnic Factor
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