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Publication

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response

Recent data suggest that the role of CYP3A4 in imatinib metabolism is smaller than presumed.…

CertaraJanuary 1, 2013

Publication

Optimal Sampling Times for a Drug and Its Metabolite Using Simcyp Simulations as Prior Information

Since 2007, it is mandatory for the pharmaceutical companies to submit a Pediatric Investigation Plan…

CertaraJanuary 1, 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

Blog Knowledge Base

Calculating Urine PK Parameters

Pharmacokinetic analysis normally focuses on systemic exposure to a drug; however, much can be learned…

CertaraDecember 6, 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

Blog Knowledge Base

Bioavailability

Discover bioavailability in pharmacokinetics, its types, the first-pass effect, and calculations. Explore tools for accurate…

CertaraNovember 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

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response

Optimal Sampling Times for a Drug and Its Metabolite Using Simcyp Simulations as Prior Information

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

Calculating Urine PK Parameters

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?

Bioavailability

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

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