September 2013 | Certara

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

Toxicokinetics/Toxicodynamics of γ-hydroxybutyrate-ethanol Intoxication: Evaluation of Potential Treatment Strategies

γ-Hydroxybutyrate (GHB), a common drug of abuse, is often coingested with ethanol. Increasing renal clearance…

CertaraSeptember 1, 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

Using Historical Control Information for the Design and Analysis of Clinical Trials with Overdispersed Count Data

Results from clinical trials are never interpreted in isolation. Previous studies in a similar setting…

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

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