BACKGROUND AND OBJECTIVES: @entity18245 Autogel(  ) ( @entity18245 Depot in the USA) has demonstrated anti- @entity5 activity and control of the symptoms associated with hormone hypersecretion in @entity1 with @entity5 . The objectives of this study were to describe the pharmacokinetics of @entity18245 Autogel(  ) administered 4-weekly by deep subcutaneous injections of 60, 90, or 120  mg in @entity1 with @entity5 ( @entity5 ), to quantify the magnitude of inter- @entity1 variability (IPV), and to identify those @entity1 characteristics that impact on pharmacokinetics. METHODS: Analyses were based on pooled data from clinical trials. A total of 1541 serum concentrations from 290 @entity1 were analyzed simultaneously by the population approach using NONMEM(  ) version  7.2. Covariates evaluated included demographics, renal and hepatic function markers, and disease-related parameters. RESULTS: Serum profiles were described by a one-compartment disposition model in which the absorption process was characterized by two parallel pathways following first- and zero-order kinetics. The estimated apparent volume of distribution was 18.3  L. The estimated apparent total serum clearance for a typical 74  kg @entity1 was 513  L/day, representing a substantial difference in clearance in this population of @entity1 with respect to healthy volunteers that could not be explained by any of the covariates tested. Body weight was the only covariate to show a statistically significant effect on the pharmacokinetic profile, but due to the overlap between the pharmacokinetic profiles of @entity1 with lower or higher body weights the effect of body weight on clearance was not considered clinically relevant. The IPV was low for clearance (27  %) and moderate to high for volume of distribution (150  %) and the absorption constant (61  %). CONCLUSIONS: Using two mechanisms of absorption, the pharmacokinetics of @entity18245 Autogel(  ) were well-described in @entity1 with GEP-NET. None of the @entity1 characteristics tested were of clinical relevance to potential dose adjustment in clinical practice.

Population Pharmacokinetic Analysis of XXXX Autogel(  )/Depot in the @entity5 : Pooled Analysis of Four Clinical Trials.

@entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'gastroenteropancreatic neuroendocrine tumors', 'neuroendocrine tumors', 'GEP-NETs'] @entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity18245 :: ('MESH:C060347', 'Chemical') :: ['lanreotide', 'Lanreotide']
@entity18245 :: (MESH:C060347,Chemical) :: ['Lanreotide']
