pre-update Archives

Publication

Pharmacokinetics, Pharmacodynamics, Physiologically-based Pharmacokinetic Modeling of Monoclonal Antibodies

Development of monoclonal antibodies (mAbs) and their functional derivatives represents a growing segment of the…

CertaraFebruary 1, 2013

Publication

Analysis of Level A In Vitro-In Vivo Correlations for an Extended-release Formulation with Limited Bioavailability

A two-stage, numerical deconvolution approach was employed to develop level A in vitro–in vivo correlations…

CertaraJanuary 21, 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

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

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

pre-update

Pharmacokinetics, Pharmacodynamics, Physiologically-based Pharmacokinetic Modeling of Monoclonal Antibodies

Analysis of Level A In Vitro-In Vivo Correlations for an Extended-release Formulation with Limited Bioavailability

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

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

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?

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