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…

Certara2013 年 9 月 1 日

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.…

Certara2013 年 9 月 1 日

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,…

Certara2013 年 9 月 1 日

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…

Certara2013 年 8 月 1 日

Publication

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

Certara2013 年 8 月 1 日

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…

Certara2013 年 7 月 24 日

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…

Certara2013 年 7 月 24 日

Publication

A Randomised Study of the Effect of Danoprevir/Ritonavir or Ritonavir on Substrates of Cytochrome P450 (CYP) 3A and 2C9 in Chronic Hepatitis C Patients Using a Drug Cocktail

Certara2013 年 7 月 20 日

Publication

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

The pharmaceutical industry continues to face significant challenges. Very few compounds that enter development reach…

Certara2013 年 7 月 1 日

Publication

Intravenous Topiramate: Safety and Pharmacokinetics Following a Single Dose in Patients with Epilepsy or Migraines Taking Oral Topiramate

Although topiramate is widely prescribed for epilepsy and migraine, there is no intravenous product. We…

Certara2013 年 6 月 1 日

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Modeling and Simulation – PK/PD

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

A Randomised Study of the Effect of Danoprevir/Ritonavir or Ritonavir on Substrates of Cytochrome P450 (CYP) 3A and 2C9 in Chronic Hepatitis C Patients Using a Drug Cocktail

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

Intravenous Topiramate: Safety and Pharmacokinetics Following a Single Dose in Patients with Epilepsy or Migraines Taking Oral Topiramate

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