Non-Compartmental Analysis of Pharmacokinetic Data: Considerations to Gain Efficiencies and Meet SEND Requirements

Pharmacokinetic (PK) data gathered in the early phases of drug discovery program can provide insights on a compound’s mechanism of action, identify specific attributes of interest and guide decision points to optimize downstream development. Selecting the most appropriate analysis technique is essential to computing PK parameters.

This article discusses how non-compartmental analysis (NCA) of pharmacokinetic data can help support regulatory filings, create predictive simulations and help researchers select lead molecules or formulations. We also explore the topic of data handling as differing approaches and anomalous results can cause delays through investigations and inconsistencies across a program. Finally, we’ll cover unique considerations when working with biologics and the challenges involved with submitting regulatory filings formatted to the Standard for Exchange of Nonclinical Data (SEND) specifications. Continue reading