Cardiac Safety Simulator
Predicts drug-induced cardiovascular risks early, enabling informed decisions and reducing costly late-stage failures.
CertaraApril 27, 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
Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia
X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…
CertaraApril 1, 2016
A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation
The published literature on mechanism based inhibition (MBI) of CYPs was evaluated with respect to…
CertaraApril 1, 2016
Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma
The purpose of this study was to characterize the pharmacokinetics of oral trametinib, a first in…
CertaraApril 1, 2016
