Understanding Steady State Pharmacokinetics

“Steady state” is an important term in pharmacokinetics, but it can often seem a bit abstract and confusing to many. Here is how I define steady state: When the rate of drug input is equal to the rate of drug elimination, steady state has been achieved. Another way to think of this is imagine a … Continued

Absence of Pharmacokinetic Drug-drug Interaction of Pertuzumab with Trastuzumab and Docetaxel

Pertuzumab is a novel antihuman epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody. Combined with trastuzumab plus docetaxel, pertuzumab improved progression-free and overall survival versus trastuzumab plus docetaxel in the phase III CLEOPATRA trial (NCT00567190) in first-line HER2-positive metastatic breast cancer. Thirty-seven patients participated in a pharmacokinetic (PK)/corrected QT interval substudy of CLEOPATRA, which … Continued

Phoenix WinNonlin: A State of the Art Software Tool for Pre-clinical PK and TK Analysis

Are you currently using Excel for PK/TK analysis? Phoenix WinNonlin streamlines analyses and generates all of the output needed for non-compartmental analysis, TK, PK and PK/PD studies from within a single, validatable environment. Highlights of this webinar included: Sophisticated plotting of PK data Calculation of key PK parameters Cmax, Tmax, AUClast, AUCinf, Clearance Statistical summary … Continued

What is Identifiability?

Developing models for pharmacokinetic or pharmacodynamic data requires creativity, patience, and hard work. Sometimes that creativity ends up violating mathematical principles which can lead to poorly fitting models and frustration for a modeler. One common area where mistakes are made is related to the analysis of parent and metabolite data simultaneously. Because data are available … Continued

Introduction to Population PK/PD Analysis Using Phoenix NLME

Phoenix NLME provides sophisticated algorithms and powerful and flexible data processing and modeling tools for population PK/PD analyses with an intuitive graphical user interface. The Phoenix system can be customized for any type of modeler from beginners to experts. Phoenix NLME is easy to learn as it has built-in PK/PD libraries that can be used … Continued