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

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

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