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Scaling Factors for the Extrapolation of In Vivo Metabolic Drug Clearance from In Vitro Data: Reaching a Consensus on Values of Human Microsomal Protein and Hepatocellularity per Gram of Liver Blog Post

Reported predictions of human in vivo hepatic clearance from in vitro data have used a variety of values for the scaling factors human microsomal protein (MPPGL) and hepatocellularity (HPGL) per…

Prediction of Plasma Protein Binding Displacement and Its Implications for Quantitative Assessment of Metabolic Drug-drug Interactions from In Vitro Data Blog Post

Although displacement from plasma protein binding (dPB) is usually of little clinical significance, it should be taken into account when interpreting changes in total plasma concentrations of drugs subject to…

Implications of Mechanism-based Inhibition of CYP2D6 for the Pharmacokinetics and Toxicity of MDMA Blog Post

The aim of this study was to model the in vivo kinetic consequences of mechanism-based inhibition (MBI) of CYP2D6 by 3,4 methylenedioxymethamphetamine (MDMA, ecstasy). A model with physiologically-based components of…

The Impact of Experimental Design on Assessing Mechanism-based Inactivation of CYP2D6 by MDMA (Ecstasy) Blog Post

MDMA (3-4-methylenedioxymethamphetamine, commonly known as Ecstasy) is a potent mechanism-based inhibitor (MBI) of cytochrome P450 2D6 (CYP2D6), causing quasi-irreversible inhibition of the enzyme in vitro. An evaluation of the in…

Prediction of Clearance of Eleven Drugs and Associated Variability in Neonates Blog Post

Prediction of the exposure of neonates, infants and children to xenobiotics is likely to be more successful using physiologically based pharmacokinetic models than simplistic allometric scaling, particularly in younger children….

Prediction of Metabolic Drug Clearance in Humans: In Vitro-In Vivo Extrapolation vs Allometric Scaling Blog Post

Previously in vitro-in vivo extrapolation (IVIVE) with the Simcyp Clearance and Interaction Simulator® has been used to predict the clearance of 15 clinically used drugs in humans. The criteria for…

Prediction of In Vivo Drug Clearance from In Vitro Data, I: Impact of Inter-individual Variability Blog Post

The Simcyp® Population-Based ADME Simulator was used to predict median drug clearances and their associated variance from in vitro data. Fifteen drugs satisfied the entry criteria for the study and…

Prediction of In Vivo Drug Clearance from In Vitro Data, II: Potential Inter-ethnic Differences Blog Post

Potential differences in drug clearance between Japanese and Caucasians were investigated by integrating data on demography, liver size, the abundance of the major cytochromes P450 and in vitro metabolic parameters….

Development of a Predictive Pharmacokinetic Model for a Novel Cyclooxygenase-2 Inhibitor Blog Post

A predictive population pharmacokinetic model was developed for a novel cyclooxygenase-2 (COX-2) inhibitor CS-706, using data from 130 subjects in 3 phase 1 trials after single or multiple doses of…

Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation Blog Post

The aim of this study was to develop a pain relief model for a cyclooxygenase (COX)-2 inhibitor, CS-706, that permits prediction of doses for acute pain relief in Japanese and…

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