Model Informed Drug Development Archives

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…

CertaraMarch 1, 2013

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…

CertaraFebruary 28, 2013

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…

CertaraFebruary 21, 2013

Publication

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…

CertaraFebruary 20, 2013

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…

CertaraJanuary 9, 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

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…

CertaraDecember 26, 2012

Publication

Novel Biocompatible Disease Modifying Nanomedicine of VIP for Rheumatoid Arthritis

Despite advances in rheumatoid arthritis (RA) treatment, efficacious and safe disease-modifying therapy still represents an…

CertaraDecember 4, 2012

Publication

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

Simulations were performed for carboplatin/paclitaxel (C/P) plus motesanib or bevacizumab vs. C/P as first-line treatment…

CertaraNovember 1, 2012

Publication

Trends in Oral Drug Bioavailability Following Bariatric Surgery: Examining the Variable Extent of Impact on Exposure of Different Drug Classes

Changes to oral drug bioavailability have been observed post bariatric surgery. However, the magnitude and…

CertaraNovember 1, 2012

Model Informed Drug Development

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

Novel Biocompatible Disease Modifying Nanomedicine of VIP for Rheumatoid Arthritis

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

Trends in Oral Drug Bioavailability Following Bariatric Surgery: Examining the Variable Extent of Impact on Exposure of Different Drug Classes

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