Model Informed Drug Development Archives

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…

CertaraOctober 1, 2007

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…

CertaraSeptember 10, 2007

Publication

Modeling, Simulation, and the Critical Path

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

CertaraSeptember 6, 2007

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…

CertaraJuly 1, 2007

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

Model Informed Drug Development

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

Time-dependent CYP Inhibition

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

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