pre-update Archives

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

Application of PBPK Modeling to Predict Monoclonal Antibody Disposition in Plasma and Tissues in Mouse Models of Human Colorectal Cancer

This investigation evaluated the utility of a physiologically based pharmacokinetic (PBPK) model, which incorporates model…

CertaraDecember 1, 2012

Knowledge Base

What Can We Learn from a Human Mass Balance Study?

Mass balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies”.…

CertaraNovember 27, 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

Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery

Edoxaban is an oral direct factor Xa inhibitor approved for the prevention of venous thromboembolism…

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

Knowledge Base

Designing a Clinical Drug-drug Interaction Study

After a much longer delay that I expected, I am back to blogging on a…

CertaraOctober 29, 2012

Publication

A Pregnancy Physiologically-based Pharmacokinetic (p-PBPK) Model for Disposition of Drugs Metabolized by CYP1A2, CYP3A4, and CYP2D6

Pregnant women are usually not part of the traditional drug development program. Pregnancy is associated…

CertaraOctober 9, 2012

pre-update

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

Application of PBPK Modeling to Predict Monoclonal Antibody Disposition in Plasma and Tissues in Mouse Models of Human Colorectal Cancer

What Can We Learn from a Human Mass Balance Study?

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

Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery

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

Designing a Clinical Drug-drug Interaction Study

A Pregnancy Physiologically-based Pharmacokinetic (p-PBPK) Model for Disposition of Drugs Metabolized by CYP1A2, CYP3A4, and CYP2D6

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