Model Informed Drug Development Archives

Publication

Predictive Population Pharmacokinetic/Pharmacodynamic Model for a Novel COX-2 Inhibitor

The objectives of these analyses were to (1) develop a population pharmacokinetic/pharmacodynamic model for a…

webdev2007年3月1日

Publication

Misuse of the Well-stirred Model of Hepatic Drug Clearance

The “well-stirred” model of hepatic drug clearance was first proposed by Gillette and established by…

webdev2007年3月1日

Publication

Time-dependent CYP Inhibition

Time-dependent inhibition (TDI) of CYP refers to a change in potency during an in vitro incubation or dosing period…

webdev2007年2月1日

Publication

Simulation and Prediction of In Vivo Drug Metabolism in Human Populations from In Vitro Data

The perceived failure of new drug development has been blamed on deficiencies in in vivo…

webdev2007年2月1日

Publication

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

Reported predictions of human in vivo hepatic clearance from in vitro data have used a…

webdev2007年1月1日

Publication

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

Although displacement from plasma protein binding (dPB) is usually of little clinical significance, it should…

webdev2006年12月1日

Publication

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

The aim of this study was to model the in vivo kinetic consequences of mechanism-based…

webdev2006年11月1日

Publication

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

MDMA (3-4-methylenedioxymethamphetamine, commonly known as Ecstasy) is a potent mechanism-based inhibitor (MBI) of cytochrome P450…

webdev2006年11月1日

Publication

Prediction of Clearance of Eleven Drugs and Associated Variability in Neonates

Prediction of the exposure of neonates, infants and children to xenobiotics is likely to be…

webdev2006年9月1日

Publication

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

Previously in vitro-in vivo extrapolation (IVIVE) with the Simcyp Clearance and Interaction Simulator® has been…

webdev2006年7月1日

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モデルに基づく医薬品開発

Predictive Population Pharmacokinetic/Pharmacodynamic Model for a Novel COX-2 Inhibitor

Misuse of the Well-stirred Model of Hepatic Drug Clearance

Time-dependent CYP Inhibition

Simulation and Prediction of In Vivo Drug Metabolism in Human Populations from In Vitro Data

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

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

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

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

Prediction of Clearance of Eleven Drugs and Associated Variability in Neonates

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

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