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Sildenafil during the 2nd and 3rd trimester of pregnancy: Trials and tribulations. The maternal model was coupled with the fetal model using the permeability-limited placental model. The predicted plasma concentration-time profile is given in Figures 2, 3 for maternal and umbilical vein plasma concentrations, respectively. This was justified given the very limited fluctuation of concentrations between troughs and peaks within each steady state dosing interval irrespective of the percentile.

It is worth mentioning here the limitations associated with fu values measured in vitro in plasma obtained from cord blood samples. Taken together, these findings suggest that maternally administered SIL during pregnancy can reach the fetus to exert its putative therapeutic effect. Based on these comparisons, the pregnancy PBPK model for sildenafil was considered adequate to be used for simulation-based dose predictions. Furthermore, taking into consideration the interindividual variability in the population, C trough C tr values at the 5th percentile were also considered for efficacy, while the C max values at the 95th percentile were used for toxicity evaluation see Table 3.

Therapeutic drug monitoring will be required to adapt the initial dosing regimen in specific patients. Interestingly, both simulation strategies based on two different fu values led to similar dose predictions. RH developed the PTA analyses and generated the graphs. Secondly, a significant increase in fu in the fetus requires a reevaluation of SIL efficacy and safety levels, expressed as total concentrations. Interestingly, the two sheep studies in this field have both demonstrated effects of sildenafil at fetal concentrations well below the currently used therapeutic range.

To obtain accurate values for the altered SIL fu values, two approaches were applied. However, it should be aurogra 75mg online that the boundaries of this therapeutic window assume a fu of 0.

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