Application of Knockout Mouse Models to Investigate the Influence of FcγR on the Pharmacokinetics and Anti-platelet Effects of MWReg30, a Monoclonal Anti-GPIIb Antibody

This work evaluates the influence of FcγR on the pharmacokinetics and pharmacodynamics of a rat anti-integrin-αIIb IgG1 monoclonal antibody, MWReg30, in mice. The pharmacokinetics and pharmacodynamics of MWReg30 were investigated in C57BL/6 control mice, FcγRI/RIII knockout mice, and FcγRIIb knockout mice, following intravenous doses of 0.04-0.4mg/kg. MWReg30 treatment resulted in a dose-dependent induction of thrombocytopenia … Continued

Certara Releases Version 7.0 of D360

Certara’s latest version of D360 adds important user desired features to support enhanced scientific data access and analysis. ST. LOUIS, MO – February 27, 2013 – Certara™, a leading provider of scientific software and consulting services to improve productivity and decision-making from drug discovery through clinical development, is pleased to announce the next major release … Continued

Saturable Drug Absorption

Drug absorption is the process by which a drug molecule moves from the site of administration to the systemic circulation. Following intravenous administration, there is no absorption process since the drug is directly introduced into the blood stream. However, for oral, intramuscular, subcutaneous, sublingual, buccal, transdermal, (and many other routes), there will be an absorption … Continued

Systems Pharmacology of the Nerve Growth Factor Pathway: Use of a Systems Biology Model for the Identification of Key Drug Targets Using Sensitivity Analysis and the Integration of Physiology and Pharmacology

The nerve growth factor (NGF) pathway is of great interest as a potential source of drug targets, for example in the management of certain types of pain. However, selecting targets from this pathway either by intuition or by non-contextual measures is likely to be challenging. An alternative approach is to construct a mathematical model of … Continued

Systems Pharmacology for Drug Discovery and Development: Paradigm Shift or Flash in the Pan?

Systems pharmacology is an emerging approach that sets out to use quantitative concepts rooted in the synergy between modeling and simulation on one hand and large-scale data collection and analysis on the other to investigate biological systems and design therapeutic interventions. Interest in this field has recently increased substantially, but so have perceived challenges and … Continued

Nonlinear PK: What Does That Mean?

You may come across a phrase like the following and wonder what it means: “… this drug exhibits nonlinear pharmacokinetics …”. An example of a drug that has nonlinear pharmacokinetics (PK) is erythropoietin or EPO. You may have heard about EPO in the context of sports because it is a performance enhancing drug (PED). EPO … Continued

Certara Supports Eleven Recent Drug Approvals through Model-based Drug Development

Pharsight Consulting Services applies quantitative models to decision making ST. LOUIS, MO – February 13, 2013 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through clinical development, published a new white paper that summarizes its involvement and support of eleven drug approvals over the past … Continued

Why Cmax is a Continuous Variable and Tmax is a Categorical Variable

The maximum observed concentration (Cmax) and the time of Cmax (tmax) are both obtained directly from the concentration-time data. In this post, I will review how to determine both of these parameters, and how to interpret information from the values. These two parameters are simple, but they pack some important information if you know how … Continued

Certara Establishes KSU College of Veterinary Medicine as Latest Phoenix Center of Excellence

Collaboration to strengthen PK/PD modeling approaches used in animal health ST. LOUIS, MO – February 5, 2013 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through clinical development, announced that the Institute of Computational Comparative Medicine (ICCM) at Kansas State University has been named a Phoenix® Center … Continued

What is Quantification Anyway?

Bioanalytical analysis is a fundamental tool for the pharmacokineticist. The results of a bioanalysis are the source data for all pharmacokinetic work. Thus a clear understanding of the methodologies and challenges associated with the bioanalytical analysis science is of great benefit to a pharmacokineticist. As an example, I was recently working on the development of … Continued