Model Informed Drug Development Archives

Publication

The Use of Mechanistic DM-PK-PD Modeling to Assess the Power of Pharmacogenetic Studies—CYP2C9 and Warfarin as an Example

The aim of this study was to assess the power of in vivo studies needed…

CertaraJuly 1, 2007

Publication

Kinetics of the Time-dependent Inactivation of CYP2D6 in Cryopreserved Human Hepatocytes by Methylenedioxymethamphetamine (MDMA)

Methylenedioxymethamphetamine (MDMA) was investigated in cryopreserved human hepatocytes as a time-dependent inactivator (TDI) of CYP2D6…

CertaraMay 1, 2007

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…

CertaraMarch 1, 2007

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…

CertaraMarch 1, 2007

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…

CertaraFebruary 1, 2007

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…

CertaraFebruary 1, 2007

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…

CertaraJanuary 1, 2007

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…

CertaraDecember 1, 2006

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…

CertaraNovember 1, 2006

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…

CertaraNovember 1, 2006

Model Informed Drug Development

The Use of Mechanistic DM-PK-PD Modeling to Assess the Power of Pharmacogenetic Studies—CYP2C9 and Warfarin as an Example

Kinetics of the Time-dependent Inactivation of CYP2D6 in Cryopreserved Human Hepatocytes by Methylenedioxymethamphetamine (MDMA)

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)

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