Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival
Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…
CertaraAugust 1, 2014
Interaction Between Domperidone and Ketoconazole: Toward Prediction of Consequent QTc Prolongation Using Purely In Vitro Information
We aimed to investigate the application of combined mechanistic pharmacokinetic (PK) and pharmacodynamic (PD) modeling…
CertaraAugust 1, 2014
Radiometric Analysis
One of the oldest methods used for the quantitation of drug molecules is radiometric analysis.…
CertaraJuly 29, 2014
FDA JumpStart: an introduction
Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…
CertaraJuly 16, 2014
Understanding LC/MS/MS
The most common bioanalytical method in use today is LC/MS/MS, or liquid chromatography (LC) tandem…
CertaraJuly 15, 2014
Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor
Dutogliptin is a selective dipeptidyl peptidase-4 inhibitor shown to be efficacious and safe in patients…
CertaraJuly 14, 2014
Simulation of Monoclonal Antibody Pharmacokinetics in Humans Using a Minimal Physiologically-based Model
Compared to small chemical molecules, antibodies and Fc-containing derivatives (mAbs) have unique pharmacokinetic behavior characterized by…
CertaraJuly 9, 2014
Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin
Typically, pharmacokinetic-pharmacodynamic (PK/PD) models use plasma concentration as the input that drives the PD model. However, interindividual variability in…
CertaraJuly 9, 2014
What is HPLC/UV?
In my series about bioanalysis for the pharmacokineticist, I thought I would start with the…
CertaraJuly 8, 2014
