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Prediction of ethnic differences in clearance
Most clinical trials in Europe and the USA are carried out in Caucasians, while those in Japan are almost exclusively in Japanese subjects.
Inter-ethnic differences in drug disposition may be the result of differences in genetic, physiological, demographic and environmental factors. Simcyp databases contain such information, allowing simulation of outcomes in different virtual populations and assessment of the impact of ethnicity. For example, specific information on demography, physiology and enzyme abundances in Japanese has been collated within Simcyp, allowing comparisons of drug disposition against Caucasian populations.
By including comprehensive population-specific data, Simcyp is able to predict drug clearance in different ethnic groups (Figure 7).
Figure 7. A comparison of observed oral clearances (CLpo) of 11 drugs in Caucasian and Oriental populations with those predicted using the Simcyp Simulator. The line of identity (black line) ± 2-fold differences (blue lines) are indicated. The x error bars indicate the variation (90% CI) in observed values and the y error bars indicate the variation in predicted values [
Inoue et al., 2006]
