2016

Publication

Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Healthy Adult Subjects Following Single and Multiple Ascending Doses

The pharmacokinetics and safety of ceftolozane, a novel cephalosporin, and tazobactam, a β-lactamase inhibitor, alone…

CertaraJune 1, 2016

Publication

Cytochrome P450 Turnover: Regulation of Synthesis and Degradation, Methods for Determining Rates, and Implications for the Prediction of Drug Interactions

In vivo enzyme levels are governed by the rates of de novo enzyme synthesis and…

CertaraJune 1, 2016

Publication

Prediction of Drug-drug Interactions Arising From CYP3A Induction Using a Physiologically-based Dynamic Model

Using physiologically-based pharmacokinetic modeling, we predicted the magnitude of drug-drug interactions (DDIs) for studies with…

CertaraJune 1, 2016

Blog

Submitting eCTD in Advance of a Milestone Application

While advanced GPS systems and the advent of Big Data analytics are negating some of…

CertaraMay 10, 2016

On-Demand Webinar

Can QSP Save Lives? Lessons from the Bial Trial Debacle

One of the biggest challenges for the pharmaceutical industry is the high rate of drug…

CertaraMay 4, 2016

Publication

Optimization of Vancomycin Dosing Regimens to Achieve Therapeutic Targets in Critically Ill Patients in Thailand

It is essential to rapidly achieve therapeutic vancomycin concentrations in critically ill patients with gram-positive…

CertaraMay 1, 2016

Publication

A Six-stage Workflow for Robust Application of Systems Pharmacology

Quantitative and systems pharmacology (QSP) is increasingly being applied in pharmaceutical research and development. One…

CertaraMay 1, 2016

Brochure

Cardiac Safety Simulator

Predicts drug-induced cardiovascular risks early, enabling informed decisions and reducing costly late-stage failures.

CertaraApril 27, 2016

Brochure

Academic Licenses

Simcyp grants academic licenses for the Simcyp Simulator to centers of excellence in research related…

CertaraApril 27, 2016

Publication

Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Kinetics in Medullary Thyroid Cancer Patients Receiving Cabozantinib

Nonlinear mixed effects models were developed to describe the relationship between cabozantinib exposure and target…

CertaraApril 27, 2016

Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Healthy Adult Subjects Following Single and Multiple Ascending Doses

Cytochrome P450 Turnover: Regulation of Synthesis and Degradation, Methods for Determining Rates, and Implications for the Prediction of Drug Interactions

Prediction of Drug-drug Interactions Arising From CYP3A Induction Using a Physiologically-based Dynamic Model

Submitting eCTD in Advance of a Milestone Application

Can QSP Save Lives? Lessons from the Bial Trial Debacle

Optimization of Vancomycin Dosing Regimens to Achieve Therapeutic Targets in Critically Ill Patients in Thailand

A Six-stage Workflow for Robust Application of Systems Pharmacology

Cardiac Safety Simulator

Academic Licenses

Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Kinetics in Medullary Thyroid Cancer Patients Receiving Cabozantinib

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