Does Age Affect Gastric Emptying Time? A Model-based Meta-analysis

Gastric emptying (GE) is often reported to be slower and more irregular in premature neonates than in older children and adults. The aim of this study was to investigate the impact of age and other covariates on the rate of GE. The effect of age on the mean gastric residence times (MGRT) of liquid and solid food was assessed by analyzing 49 … Continued

Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents

Quetiapine is an atypical antipsychotic drug with a high permeability, moderate solubility and defined as a Biopharmaceutics Classification System class ll compound. The pharmacokinetics (PK) of the quetiapine immediate-release (IR) formulation has been studied in both adults and children, but the quetiapine extended-release (XR) formulation has only been conducted in adults. The purpose of the … Continued

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power

The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to reproduce the influence of haematocrit on the clearance of tacrolimus, observed previously, and to assess the power of clinical studies to detect the effects of covariates on the clearance of tacrolimus. A population-based pharmacokinetic simulator (Simcyp®) was used to simulate … Continued

A Physiologically-based Pharmacokinetic (PBPK) Approach to Evaluate Pharmacokinetics in Patients with Cancer

Potential differences in pharmacokinetics (PK) between healthy subjects and patients with cancer were investigated using a physiologically based pharmacokinetic approach integrating demographic and physiological data from patients with cancer. Demographic data such as age, sex and body weight, and clinical laboratory measurements such as albumin, α-1 acid glycoprotein (AAG) and hematocrit were collected in ~2500 … Continued

Analysis of Level A In Vitro-In Vivo Correlations for an Extended-release Formulation with Limited Bioavailability

A two-stage, numerical deconvolution approach was employed to develop level A in vitro–in vivo correlations using data for three formulations of an extended-release oral dosage form. The in vitro dissolution data for all formulations exhibited near-complete dissolution within the time frame of the test. The pharmacokinetic concentration–time profiles for 16 subjects in a cross-over study … Continued

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