Limited Sampling Strategy for Accurate Prediction of Pharmacokinetics of Saroglitazar: A 3-point Linear Regression Model Development and Successful Prediction of Human Exposure

A 3-concentration−time points limited sampling model predicts the exposure of saroglitazar (ie, AUC0−t) within predefined acceptable bias and imprecision limit. Same model was also used to predict AUC0−∞. The same limited sampling model was found to predict the exposure of saroglitazar sulfoxide within predefined criteria. This model can find utility during late-phase clinical development of saroglitazar in the patient population.