Parameter Estimation and Reporting in Noncompartmental Analysis of Clinical Pharmacokinetic Data

Abstract The noncompartmental analysis (NCA) of pharmacokinetic (PK) data is important throughout all phases of clinical drug development. Although there are numerous regulatory guidances and articles in the literature concerned with best practices for the modeling of PK data, there are relatively few sources of information on how to conduct a high‐quality NCA. This article provides a systematic review of issues related to the estimation of plasma and urine PK parameters with the intent of encouraging rigor in the performance of NCAs so as to provide reliable and informative analysis results.