Model Informed Drug Development Archives

Publication

Axitinib in Metastatic Renal Cell Carcinoma: Results of a Pharmacokinetic and Pharmacodynamic Analysis

Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1, 2,…

Certara2013 年 3 月 28 日

Publication

A Poor Metabolizer of Both CYP2C19 and CYP2D6 Identified by Mechanistic Pharmacokinetic Simulation in a Fatal Drug Poisoning Case Involving Venlafaxine

We present a fatal drug poisoning case involving venlafaxine (VEN). The deceased took his medication…

Certara2013 年 3 月 10 日

Publication

Race and Drug Formulation Influence on Mycophenolic Acid Pharmacokinetics in Stable Renal Transplant Recipients

Limited mycophenolic acid (MPA) data are available comparing racial influence on mycophenolate mofetil (MMF) and…

Certara2013 年 3 月 1 日

Publication

In Vitro to Human In Vivo Translation—Pharmacokinetics and Pharmacodynamics of Quinidine

The translational sciences aim to transfer results from basic research to the treatment of animals…

Certara2013 年 3 月 1 日

Publication

Application of Knockout Mouse Models to Investigate the Influence of FcγR on the Pharmacokinetics and Anti-platelet Effects of MWReg30, a Monoclonal Anti-GPIIb Antibody

This work evaluates the influence of FcγR on the pharmacokinetics and pharmacodynamics of a rat…

Certara2013 年 2 月 28 日

Publication

Systems Pharmacology of the Nerve Growth Factor Pathway: Use of a Systems Biology Model for the Identification of Key Drug Targets Using Sensitivity Analysis and the Integration of Physiology and Pharmacology

The nerve growth factor (NGF) pathway is of great interest as a potential source of…

Certara2013 年 2 月 21 日

刊物

Systems Pharmacology for Drug Discovery and Development: Paradigm Shift or Flash in the Pan?

Systems pharmacology is an emerging approach that sets out to use quantitative concepts rooted in…

Certara2013 年 2 月 20 日

Publication

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus

The G-protein-coupled receptor 40 agonist (GPR40) TAK-875 is being developed as an adjunct to diet…

Certara2013 年 1 月 9 日

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…

Certara2013 年 1 月 1 日

Publication

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

A phase II trial in metastatic breast cancer (MBC) (NO16853) failed to show noninferiority (progression-free…

Certara2012 年 12 月 26 日

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Axitinib in Metastatic Renal Cell Carcinoma: Results of a Pharmacokinetic and Pharmacodynamic Analysis

A Poor Metabolizer of Both CYP2C19 and CYP2D6 Identified by Mechanistic Pharmacokinetic Simulation in a Fatal Drug Poisoning Case Involving Venlafaxine

Race and Drug Formulation Influence on Mycophenolic Acid Pharmacokinetics in Stable Renal Transplant Recipients

In Vitro to Human In Vivo Translation—Pharmacokinetics and Pharmacodynamics of Quinidine

Application of Knockout Mouse Models to Investigate the Influence of FcγR on the Pharmacokinetics and Anti-platelet Effects of MWReg30, a Monoclonal Anti-GPIIb Antibody

Systems Pharmacology of the Nerve Growth Factor Pathway: Use of a Systems Biology Model for the Identification of Key Drug Targets Using Sensitivity Analysis and the Integration of Physiology and Pharmacology

Systems Pharmacology for Drug Discovery and Development: Paradigm Shift or Flash in the Pan?

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus

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

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

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