TABLE 8

Clinically observed and Simcyp model-predicted PK parameters of panobinostat on cycle 1, day 8 (in the absence of DEX) and on cycle 2, day 8 (in the presence of DEX)

PK ParameteraPanobinostat AlonePanobinostat + DEXGeometric Mean Ratio
Cmax ng/mlObservedb (n = 12–15)9.5 (60.4)8.1 (90.3)0.85
Predicted (n = 100)12.313.60.90
Prediction error (%)c
AUC0-24 ng × h/mlObserved (n = 12–15)61.8 (60.9)47.5 (76.8)0.77
Predicted (n = 100)11799.30.85
Prediction error (%)
  • a Values are the geometric mean (CV%).

  • b Observed values are from Mu et al. (2016) and San-Miguel et al. (2013).

  • c Prediction error % = [(predicted-observed)/observed] × 100.