Month: August 2014
Accounting for Ethnic and Sex differences in QTc Prolongation Using Heart Drug Concentrations with Physiologically-based Pharmacokinetic/Pharmacodynamic (PBPK/PD) Models
Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies
Adding a Placebo Component to Your PK/PD Model in Phoenix
PK/PD modeling is an exciting are of research in clinical pharmacology. Most often we try to model the effect of a drug by drawing relationships between the concentration and effect. This usually entails subsetting the data to exclude information from subject that received placebo during the trial. But statistical comparisons in clinical studies are most … Continued
Lack of Angiopoietin-like-2 Expression Limits the Metabolic Stress Induced by a High-fat Diet and Maintains Endothelial Function in Mice
Angiopoietin-like-2 (angptl2) is produced by several cell types including endothelial cells, adipocytes and macrophages, and contributes to the inflammatory process in cardiovascular diseases. We hypothesized that angptl2 impairs endothelial function, and that lowering angptl2 levels protects the endothelium against high-fat diet (HFD)-induced fat accumulation and hypercholesterolemia. Acute recombinant angptl2 reduced (P<0.05) acetylcholine-mediated vasodilation of isolated … Continued
Multi-criteria Drug Discovery: Using CoMFA Models to Drive Target Specificity
Bioanalytical Calibration Curves
At the request of a reader, I have decided to extend my series on bioanalysis to include another topic: calibration curves. The calibration curve is they keystone of bioanalysis. It is what links the instrument response to a specific concentration of drug. It is like the magic decoder ring that helps you decipher the hidden … Continued
Certara’s New Muse Invent Allows Researchers to Design Synthetically Feasible Drug Candidates
A breakthrough development, Muse Invent enables researchers not only to design dream molecules, but it also shows how to produce them in the lab ST. LOUIS, MO – Aug. 11, 2014 – Certara®, the leading global technology-enabled drug development and drug safety consultancy, announced today that its Muse molecular design workflow for the identification and … Continued
A Student’s Perspective on Using Phoenix NLME for PopPK Analysis of an Intranasal Combination Drug
The pharmacokinetic dispositions and the underlying variability of Kovacaine Mist®, a combination product containing oxymetazoline and tetracaine, were investigated by nonlinear mixed effects modeling using Phoenix® NLME. The project utilized the different plugins in the Phoenix platform allowing all steps of model development right from data setup to producing publication quality graphs in a single … Continued
Bioanalytical Method Validation
In this final post regarding bioanalysis, I will review a few of the main ideas related to bioanalytical method validation. The purpose of a method validation is to demonstrate that a specific bioanalytical method can reliably determine the concentration of drug in a study sample with a high degree of confidence. Validation does not mean … Continued