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…

webdev2006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…

webdev2006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…

webdev2006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…

webdev2006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…

webdev2005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…

webdev2005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…

webdev2005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…

webdev2005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…

webdev2005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…

webdev2005年4月1日

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モデルに基づく医薬品開発

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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