The methods used to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of a compound can be inherently complex and sophisticated. PK/PD analysis is a science that requires a mathematical and statistical background, combined with an understanding of biology, pharmacology, and physiology. PK/PD analysis guides critical decisions in drug development, such as optimizing the dose, frequency and duration of exposure, so getting these decisions right is paramount. Selecting the tools for making such decisions is equally important. Fortunately, PK/PD analysis software has evolved greatly in recent years, allowing users to focus on analysis, as opposed to algorithms and programming languages.
Nobel Prize Laureate Barbara McClintock famously said, “They were so intent on making everything numerical that they frequently missed seeing what was there to be seen,” (Gabrielsson and Weiner, 2000). This paper will focus on key considerations when selecting a software package for PK/PD analysis that will demystify the art and science of mathematical modeling, and allow a scientist to “see what needs to be seen.” A robust software solution should be easy to use and address the three main parts of the PK/PD workﬂow: data management, analysis, and reporting.