Model Informed Drug Development Archives

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…

Danielle Pillsbury2006 年 6 月 1 日

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…

Danielle Pillsbury2006 年 6 月 1 日

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…

Danielle Pillsbury2006 年 5 月 1 日

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…

Danielle Pillsbury2006 年 4 月 1 日

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…

Danielle Pillsbury2005 年 11 月 1 日

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…

Danielle Pillsbury2005 年 10 月 7 日

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…

Danielle Pillsbury2005 年 9 月 1 日

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…

Danielle Pillsbury2005 年 9 月 1 日

Publication

Modelling Approaches to Dose Estimation in Children

Most of the drugs on the market are originally developed for adults and dosage selection…

Danielle Pillsbury2005 年 6 月 1 日

Publication

Techniques: Application of Systems Biology to Absorption, Distribution, Metabolism, Excretion, and Toxicity

It is widely recognized that either predicting or determining the absorption, distribution, metabolism, excretion and…

Danielle Pillsbury2005 年 4 月 1 日

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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

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

Modelling Approaches to Dose Estimation in Children

Techniques: Application of Systems Biology to Absorption, Distribution, Metabolism, Excretion, and Toxicity

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