Modeling and Simulation - PK/PD Archives | Page 28 of 37

Publication

Inhibitory Effect of Ketoconazole on the Pharmacokinetics of a Multireceptor Tyrosine Kinase Inhibitor BMS-690514 in Healthy Participants: Assessing the Mechanism of the Interaction with Physiologically-based Pharmacokinetic Simulations

BMS-690514, a selective inhibitor of the ErbB and vascular endothelial growth factor receptors, has shown…

CertaraFebruary 1, 2013

Publication

Bioavailability of Intranasal vs. Rectal Diazepam

There remains an unmet medical need in the out-of-hospital management of seizure emergencies because older…

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

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

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

Modeling and Simulation – PK/PD

Inhibitory Effect of Ketoconazole on the Pharmacokinetics of a Multireceptor Tyrosine Kinase Inhibitor BMS-690514 in Healthy Participants: Assessing the Mechanism of the Interaction with Physiologically-based Pharmacokinetic Simulations

Bioavailability of Intranasal vs. Rectal Diazepam

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

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

What Can We Learn from a Human Mass Balance Study?

Bioavailability

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