pre-update Archives

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

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

White Paper

Transform Your Early Drug Development with Population Pharmacokinetic Analysis

Population pharmacokinetic analysis has become a key tool for Clinical Pharmacology experts when working with…

CertaraApril 19, 2016

Publication

Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the…

CertaraApril 14, 2016

Publication

Pharmacokinetics and Pharmacodynamics of Gamithromycin in Pulmonary Epithelial Lining Fluid in Naturally Occurring Bovine Respiratory Disease in Multisource Commingled Feedlot Cattle

The objectives of this study were to determine (i) whether an association exists between individual…

CertaraApril 1, 2016

pre-update

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

Academic Licenses

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

Transform Your Early Drug Development with Population Pharmacokinetic Analysis

Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

Pharmacokinetics and Pharmacodynamics of Gamithromycin in Pulmonary Epithelial Lining Fluid in Naturally Occurring Bovine Respiratory Disease in Multisource Commingled Feedlot Cattle

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