Pharmacokinetic (PK) analysis is key in drug development and bioequivalence studies, requiring precise and efficient data processing. Aplos NCA is designed to streamline and enhance PK analysis with cutting-edge automation. We are excited to introduce new features that address common challenges faced by researchers, making data analysis faster, more accurate, and easier than ever before.
We are so happy to announce that we have added 2 features that are revolutionary for PK analysis.
We have added the ability to analyze single dose and steady-state data in a single analysis. All other desktop software requires you to create separate datasets for the single dose and steady-state data. Then after analyzing separately, you have to merge the results back together. This is time consuming and requires twice the effort. With Aplos NCA, you simply specify that the dosing frequency is in a column in the dataset. In that column, you list "single" for single dose data and "steady-state" for steady state data. During analysis, Aplos NCA will calculate the correct parameters for each profile based on the dosing frequency column specified.
The second feature is the ability to analyze data from multiple routes of administration in a single analysis. For example, absolute bioavailability studies may include IV bolus and oral administration. And many times, each route has a different dose amount. Other software packages require you to split the data into 2 separate datasets and analyze each independently. At Aplos, we recognize how valuable your time is, so we allow you to specify the route of administration and dose amount via a column in the dataset. As the data is read in, the analysis can switch between IV bolus or extravascular PK parameter calculations as needed. These 2 new capabilities of Aplos NCA set our platform apart from desktop tools, and highlight our focus on making data analysis easier, automated, and lightning fast.
Besides the two game-changing features we worked on:
Partial AUC calculations are an important tool in pharmacokinetic analysis, particularly for the assessment of drug absorption. They are used in both innovator drug development programs, and when conducting bioequivalence studies. With Aplos NCA, users can add as many partial AUC values to their analysis as needed. They just need to specify the start and stop times for the partial AUC, and Aplos NCA takes care of the rest.
Data exclusions are a fact of life in pharmacokinetic analysis. However, in most software packages, you have to scrub the data before analyzing it. That means that your analysis file doesn’t match the raw data. However, Aplos NCA has the ability to filter data on the fly. You specify a column (e.g. PKANAL01) that contains exclusion codes and then the specific exclusion code used. When you run the analysis with the full dataset, Aplos NCA will exclude any records that match the exclusion code and then run the analysis on the filtered data. That way your analysis dataset will exactly match your source dataset that you submit to regulators.
Sparse data pharmacokinetic analysis is essential for small animal studies. It is used mostly in pre-clinical, discovery research, and toxicology studies. In these studies, there isn’t enough blood in the animal to create a full PK profile, so we draw samples from different animals and then create a single PK profile across multiple animals. Aplos NCA can perform sparse data pharmacokinetic analysis with a single setting. After you tell us that it is sparse data, we take care of the rest and provide the necessary summarization and outputs.
With these updates, Aplos NCA continues to redefine the standards of pharmacokinetic analysis. Our goal is to empower researchers with the most efficient tools available, allowing for more accurate studies with minimal effort. We are committed to making data analysis seamless so that you can focus on advancing research and innovation.
Get in touch with us and learn more about: info@aplosanalytics.com