Posaconazole PK/PD in clinical studies Sample Clauses

Posaconazole PK/PD in clinical studies. Although controversial, some studies suggest an exposure-response relationship for both prophylaxis and treatment of IFD in patients. As a certain amount of patients receiving the oral suspension showed low plasma concentrations [2, 79, 87-90], this indicates that therapeutic drug monitoring (TDM) may be needed to ensure adequate exposure [88, 89, 91-93]. Prophylaxis In general it can be stated that target concentrations for posaconazole prophylaxis are still under debate [87, 94]. A lower boundary of steady-state Cavg of 0.7 mg/L for posaconazole is accepted as a target for prophylaxis by the FDA and in European guidelines [95, 96], which was supported by the analysis from two randomized, active-controlled clinical studies [87]. Posaconazole trough concentrations (Cmin) proved to be well correlated with Cavg or AUC0-24 [32, 97]. Thus, Cmin is also frequently used for TDM measures in practice and considered as a more conservative and practicable index [30, 98]. A recent meta-analysis indicated that a Cmin of 0.5 mg/L could represent a clear margin separating successful from failed prophylaxis [99].
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