Comparison of model prediction of FX and FII relationship with baseline INR vs published data to validate the models. (A-B) The FX relationship is shown in panel A and the FII relationship in panel B. The black line represents the baseline factor level–baseline INR relationship from model simulations. The observed data from the phase 3 trials (used to generate the models) is plotted with black circles. Observed data obtained from published studies, which investigated the FX-INR relationship (Gulati et al³¹ ) and the FII-INR relationship (Gulati et al³¹  and Baumann Kreuziger et al³² ) in patients are represented by lavender squares and red crosses, respectively. *Model predictions for baseline INR levels of 1.6 to 10.