Model Informed Drug Development Archives

Publication

Comparison of Different Approaches to Predict Metabolic Drug-drug Interactions

Three approaches were compared to predict the actual magnitude of drug interaction (the mean fold-change in the area under…

Certara2007年10月1日

Publication

Prediction of Intestinal First-pass Drug Metabolism

Despite a lower content of many drug metabolising enzymes in the intestinal epithelium compared to…

Certara2007年10月1日

Publication

Disparity in Holoprotein/Apoprotein Ratios of Different Standards Used for Immunoquantification of Hepatic Cytochrome P450 Enzymes

An analysis of reported hepatic abundances of CYP3A4 and 3A5 indicated that values determined by…

Certara2007年10月1日

Publication

A Systematic Comparison of Software Dedicated to Meta-analysis of Causal Studies

Our objective was to systematically assess the differences in features, results, and usability of currently…

Certara2007年9月10日

Publication

Modeling, Simulation, and the Critical Path

The benefits of modeling and simulation fall into two categories: Increased certainty in trial designs…

Certara2007年9月6日

Publication

Theoretical Assessment of a New Experimental Protocol for Determining Kinetic Values Describing Mechanism (time)-based Enzyme Inhibition

We have shown previously that the conventional experimental protocol (CEP) used to characterise mechanism-based enzyme…

Certara2007年7月1日

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…

Certara2007年7月1日

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…

Certara2007年5月1日

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…

Certara2007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…

Certara2007年3月1日

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モデルに基づく医薬品開発

Comparison of Different Approaches to Predict Metabolic Drug-drug Interactions

Prediction of Intestinal First-pass Drug Metabolism

Disparity in Holoprotein/Apoprotein Ratios of Different Standards Used for Immunoquantification of Hepatic Cytochrome P450 Enzymes

A Systematic Comparison of Software Dedicated to Meta-analysis of Causal Studies

Modeling, Simulation, and the Critical Path

Theoretical Assessment of a New Experimental Protocol for Determining Kinetic Values Describing Mechanism (time)-based Enzyme Inhibition

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

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