Pharmacodynamic Evaluation: Cardiovascular Methodologies

Abstract

Cardiovascular methods to assess pharmacodynamics nowadays evolve very quickly, due to rapid progress in high technology and IT sector. Noteworthy, mathematical approach grows very fast in new algorithms to analyze the heart signal. Many areas of multiple organ damage will relay in very complex software and hardware innovations. Basics for this growth is understanding of previously unknown mechanisms of control of physiological functioning like heart stiffness and compliance. Other reasons go to research in Shannon’s entropy and derived calculations. On the other hand, some previous methods have been surpassed like arterial pulse methods when it comes to pharmacodynamics research. It is of importance also to take into account rare diseases and various channelopathies that may interfere with pharmacodynamics evaluation on large-scale clinical trials. In phases III and IV of clinical research, those factors may influence final statistical results. New tests and old proven measures of hemodynamic stabilities are required to evaluate new therapeutics during clinical studies to be able to treat more people on pharmacogenetic basis with pharmacogenomic approach. Safety to treat with new drugs comes into the first place, so many requirements in monitoring of data gathered by contract research organization (CRO) are necessary to get the approval of FDA and European Medicines Agency (EMA) is the European Union’s equivalent to the U.S. Food and Drug Administration (FDA). Those approvals mainly rely on pharmacodynamics data pooled out from clinical drug researches. To be more rapidly accessible, adverse effects are collected via wireless technologies and monitored on wider basis across multicentric studies. Therefore, guidelines on consistent methodology toward new therapeutics approach are adopted constantly.