Non-Compartmental Analysis And The Early Phase Regulatory Environment

By Esha Senchaudhuri, with thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input.

Old Fyodor was hardly talking about clinical trials, but early phase trial sponsors can probably relate to a regulatory environment which requires systematic attention to details, the little details and all these little details. When conducting early phase studies, global regulators require submission of Non -Compartmental Analyses (NCAs) that measure factors such as extent and rate of exposure to a drug, without the complexity of strenuous assumptions or complex models. Through the use of rudimentary methods such as linear trapezoidal rules, NCAs make it relatively easy to measure the concentration of a drug in a body over time. They can capture length of exposure, and time of peak exposure, without the challenges of models that require independent validation [1]. While those other models are also becoming more common in quantitative pharmacometrics, ideally NCAs can complement these other methods.