Noncompartmental PK analysis (NCA) is a standard, efficient, and effective method for estimating PK parameters and is indispensable for characterizing PK within a single study and for making time-critical dosing decisions (e.g., within dose escalation trials). Parameters from NCAs are also routinely used by regulatory authorities to inform their decision making both during development and during the approval process. Allucent will make sure your NCA is performed correctly and to the highest standard to ensure you get the most out of your data, setting your program up for success.
What is NCA?
NCA is a type of analysis that provides the most elementary pharmacokinetic (PK) information for a drug (i.e., peak concentration and elimination half-life). NCAs are essential for characterizing new drug products and can help guide drug development at each stage. NCAs often prove to be faster and more cost-efficient compared to more complex compartmental analyses (e.g., population PK analyses). As the name would imply, noncompartmental analyses do not rely upon assumptions about bodily compartments. In addition, NCAs rely almost exclusively upon simple algebraic equations to estimate PK parameters, making the analysis less complex than compartmental methods.
When to Use NCA
Deciding whether to use an NCA versus a compartmental approach is not a function of how sophisticated the method is but really depends upon the purpose of the analysis and the design of the study. NCAs require rich sampling across the entire concentration versus time profile and are most commonly utilized in early phase or clinical pharmacology studies. Compartmental models can integrate both rich and sparse sampling and are often utilized to analyze Phase 2 and 3 studies with fewer samples per subject.
NCAs are typically favored for characterizing PK within a single study, including both final analyses and any interim analyses used to make dose escalation decisions. In addition, NCA is the most commonly used approach for establishing the initial exposure characteristics of a drug prior to entry into the clinic (i.e., during nonclinical PK and toxicology studies).