Publication Archives

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…

CertaraJuly 1, 2006

Publication

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

The Simcyp® Population-Based ADME Simulator was used to predict median drug clearances and their associated…

CertaraJune 1, 2006

Publication

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

Potential differences in drug clearance between Japanese and Caucasians were investigated by integrating data on…

CertaraJune 1, 2006

Publication

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

A predictive population pharmacokinetic model was developed for a novel cyclooxygenase-2 (COX-2) inhibitor CS-706, using…

CertaraMay 1, 2006

Publication

Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation

The aim of this study was to develop a pain relief model for a cyclooxygenase…

CertaraApril 1, 2006

Publication

Changes in Liver Volume from Birth to Adulthood: A Meta-analysis

A diversity of equations is available for the estimation of liver volume (LV), derived from…

CertaraDecember 1, 2005

Publication

Kinetic Values for Mechanism-based Enzyme Inhibition: Assessing the Bias Introduced by the Conventional Experimental Protocol

The in vitro characterisation of a mechanism-based enzyme inactivator (MBEI) includes determination of the maximum…

CertaraNovember 1, 2005

Publication

Model-based Development of Gemcabene, a New Lipid-altering Agent

The purpose of this study was to evaluate the value of model-based, quantitative decision making…

CertaraOctober 7, 2005

Publication

Model-based Covariate Pharmacokinetic Analysis and Lack of Cortisol Suppression by the New Inhaled Corticosteroid Ciclesonide Using a Novel Cortisol Release Model

Ciclesonide is a novel and effective inhaled corticosteroid for the treatment of asthma that is…

CertaraSeptember 1, 2005

Publication

Therapeutic Benefit of Eletriptan Compared to Sumatriptan for the Acute Relief of Migraine Pain—Results of a Model-based Meta-analysis that Accounts for Encapsulation

A novel model-based meta-analysis was used to quantify the dose-response relationship of sumatriptan and eletriptan…

CertaraSeptember 1, 2005

Publication

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

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

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

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

Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation

Changes in Liver Volume from Birth to Adulthood: A Meta-analysis

Kinetic Values for Mechanism-based Enzyme Inhibition: Assessing the Bias Introduced by the Conventional Experimental Protocol

Model-based Development of Gemcabene, a New Lipid-altering Agent

Model-based Covariate Pharmacokinetic Analysis and Lack of Cortisol Suppression by the New Inhaled Corticosteroid Ciclesonide Using a Novel Cortisol Release Model

Therapeutic Benefit of Eletriptan Compared to Sumatriptan for the Acute Relief of Migraine Pain—Results of a Model-based Meta-analysis that Accounts for Encapsulation

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