@entity10924 is a novel glucocorticoid that is converted into @entity10924 --active principle (CIC-AP) in the lung. The study objectives were to identify a structural model for population pharmacokinetic (PK) analysis of CIC-AP using nonlinear mixed-effects modeling, assess the influence of select covariates on PK and/or pharmacodynamic (PD) parameters, and investigate the effects of CIC-AP on endogenous @entity701 . Pooled concentration data from nine phase I studies (dose: 400-3600 micrograms) involving healthy and @entity748 @entity1 were included in the PK analysis. There were 151 subjects (3300 observations) for the CIC-AP population PK analysis. Various models examined inter- and intrasubject variability for the PK parameters. Population estimates of the PK parameters of clearance and volume of distribution were 396 L/h (64.8% co-efficient of variation [CV]) and 1190 L (41.2% CV), respectively. Pharmacodynamic population estimates included maximum @entity701 release rate, 3140 ng/h (5.4% CV). The EC50 of CIC-AP was 0.88 ng/mL. @entity10924 is a safe corticosteroid that causes negligible @entity701 suppression. The disposition and effect of CIC-AP can be described using mixed-effect modeling. The estimated EC50 is similar to mean Cmax from an 800-micrograms dose, further suggesting CIC-AP has little effect on @entity701 suppression.

Population pharmacokinetics and pharmacodynamics of XXXX .

@entity701 :: ('MESH:D006854', 'Chemical') :: ['cortisol'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity748 :: ('MESH:D013224', 'Disease') :: ['asthmatic'] @entity10924 :: ('MESH:C120481', 'Chemical') :: ['ciclesonide', 'Ciclesonide']
@entity10924 :: (MESH:C120481,Chemical) :: ['ciclesonide']
