Noncompartmental analysis (NCA) provides the most elementary pharmacokinetic information for a drug (i.e., peak concentration and elimination half-life). NCAs are essential for characterizing new drug products and can help guide development at each stage. NCAs often prove to be a faster and more cost-efficient type of analyses to perform, especially when compared to more complex compartmental analyses (e.g., population PK analyses that can utilize sparse sampling techniques).
As the name would imply, NCAs do not rely upon assumptions about body compartments, and they provide more analyst-to-analyst consistency than compartmental approaches. In addition, NCAs rely almost exclusively upon simple algebraic equations to estimate PK parameters, making the analysis less complex than compartmental methods.
Advantages of NCA
Among the available strategies for PK analyses, the NCA approach provides a number of advantages. It 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 pharmaceutical companies and regulatory authorities to inform their decision making during both development and during the approval process.
When to Use NCA
Deciding whether to use a noncompartmental analysis versus a compartmental approach is not a function of how sophisticated the method is but really depends in large part 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).
Nuventra’s NCA Experience
Nuventra was originally founded on noncompartmental analysis. Looking back at our early years of consulting, we almost exclusively performed NCAs for our clients.
Today, we perform on average, at least one NCA per week. Our scientists have worked on over 3,000 NCAs throughout their combined years of experience. Some of our consultants have performed hundreds of NCAs throughout their career. Lastly, Nuventra has run NCAs for more than 100 of our clients.
Make sure your NCA is performed correctly and to the highest standard. Nuventra will help you get the most out of your data and help set up your program for success.
Contact our team of experienced consultants to perform your noncompartmental analyses at any stage in the drug development process.