Modeling and Simulation - PK/PD Archives | Page 34 of 46

Publication

Differential Pharmacokinetics of Ganitumab in Patients with Metastatic Pancreatic Cancer Versus Other Advanced Solid Cancers

Ganitumab is an investigational, fully human monoclonal antibody antagonist of the insulin-like growth factor-1 receptor…

CertaraOctober 1, 2013

Publication

Exposure-response Analysis of Pertuzumab in HER2-positive Metastatic Breast Cancer: Absence of Effect on QTc Prolongation and Other ECG Parameters

The phase III trial of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus…

CertaraSeptember 3, 2013

Publication

Pharmacokinetics of a Three-way Drug Interaction Between Danoprevir, Ritonavir, and the Organic Anion Transporting Polypeptide (OATP) Inhibitor Ciclosporin

CertaraSeptember 1, 2013

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux

A prerequisite for the prediction of the magnitude of P-glycoprotein (P-gp)-mediated drug-drug interactions between digoxin…

CertaraSeptember 1, 2013

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo.…

CertaraSeptember 1, 2013

Publication

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

Siponimod is an oral selective modulator of sphingosine 1-phosphate receptor types 1 and type 5,…

CertaraSeptember 1, 2013

Publication

A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers

Diazepam rectal gel (Diastat®) is the only FDA-approved product indicated for acute repetitive seizures. Despite…

CertaraAugust 1, 2013

Publication

Pharmacokinetic-pharmacodynamic Determinants of Oseltamivir Efficacy Using Data from Phase 2 Inoculation Studies

CertaraAugust 1, 2013

Publication

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis

Clinical trial simulation (CTS) and model-based meta-analysis (MBMA) can increase our understanding of small, first-in-patient…

CertaraJuly 24, 2013

Publication

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion…

CertaraJuly 24, 2013

Modeling and Simulation – PK/PD

Differential Pharmacokinetics of Ganitumab in Patients with Metastatic Pancreatic Cancer Versus Other Advanced Solid Cancers

Exposure-response Analysis of Pertuzumab in HER2-positive Metastatic Breast Cancer: Absence of Effect on QTc Prolongation and Other ECG Parameters

Pharmacokinetics of a Three-way Drug Interaction Between Danoprevir, Ritonavir, and the Organic Anion Transporting Polypeptide (OATP) Inhibitor Ciclosporin

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

A Pilot Study Assessing the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration in Healthy Volunteers

Pharmacokinetic-pharmacodynamic Determinants of Oseltamivir Efficacy Using Data from Phase 2 Inoculation Studies

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

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