Drug Development Archives

Publication

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion…

CertaraJuly 24, 2013

Publication

Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption

The use of whole body physiological-based pharmacokinetic (PBPK) models linked with in vitro-in vivo extrapolation…

CertaraJanuary 1, 2013

Publication

Applications of Physiologically-based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the…

CertaraFebruary 1, 2011

Publication

Population-based Mechanistic Prediction of Oral Drug Absorption

The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal…

CertaraJune 1, 2009

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

Drug Development

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption

Applications of Physiologically-based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

Population-based Mechanistic Prediction of Oral Drug Absorption

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

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