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…
Certara2013年10月1日
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…
Certara2013年9月3日
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…
Certara2013年9月1日
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.…
Certara2013年9月1日
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,…
Certara2013年9月1日
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…
Certara2013年8月1日
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…
Certara2013年7月24日
