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
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
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
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
Academic Licenses
Simcyp grants academic licenses for the Simcyp Simulator to centers of excellence in research related…
CertaraApril 27, 2016
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
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
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
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
Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2
Transporter mRNA and protein expression data are used to extrapolate in vitro transporter kinetics to in…
CertaraApril 1, 2016
