New Release Format

We are updating our release information to be friendlier for validated environment for our customers. We will continue to evolve this over time, so look for changes here.

Release: R2026-10
Release date: 16 October 2026
Breaking changes: None

Summary

R2026-10 adds Plot Themes, archiving and restoring of executions, and a new Custom Calculation conversion option. It also improves diagnostics and validation messaging and fixes several issues with result export, PK model fitting, and the administrator audit log.

GxP impact of this release (78 completed tickets): 8 Medium, 13 Low, 57 None. Medium and Low items are tagged on each entry below and listed in the GxP Impact Summary. Ratings are our assessment against typical regulated use. Customers should assess them against their own configuration and intended use.

GxP impact key: 🔴 Medium (assess and consider targeted regression testing) · 🟡 Low (review) · ⚪ None

Calculations and Results

Full output when KEL cannot be calculated — 🔴 Medium

Fixed a defect where output was incomplete when the terminal elimination rate constant (KEL) could not be calculated. Full output is now reported. (NE-1896)
Suggested check: re-run an analysis with a profile where KEL is not estimable and confirm the output is complete.

Full results exported for combined single-dose and steady-state analyses — 🔴 Medium

Fixed a defect where full results were not exported when single-dose and steady-state profiles were combined in one analysis. (NE-1852)
Suggested check: confirm result file contents for analyses that mix dosing designs.

PK model fitting results for models with lag time — 🔴 Medium

Fixed a defect where no fitting results were returned for models that include a lag time (tlag). (NE-1840)
Suggested check: confirm fitting output for extravascular profiles.

Custom Calculation: use a column as the conversion value — 🟡 Low

Conversions in Custom Calculations can now take their value from a column in addition to a fixed number. (NE-1831)

Parameter code (paramcd) registry — 🔴 Medium

Internal refactor and consolidation of how parameter codes are registered in the calculation engine. No user-facing change is intended. (NE-1854, NE-1855)
Suggested check: confirm parameter names and codes in results are unchanged from the previous release.

Plots and Tables

Plot Themes — 🟡 Low (engine, API, and data storage); ⚪ None (UI)

Users can now create and manage themes that control the look of plots. A set of packaged system themes is included. Themes carry a schema version, and existing plots and themes are migrated automatically when the schema changes. Tenant users can create themes. Includes a UI designer, a management page, and API and CDN support. (NE-1707, 1708, 1709, 1710, 1711, 1712, 1902, 1918, 1948, 1952)
Note: existing plots are migrated to the new theme schema. The UI migration indicator now refreshes when migration completes. (NE-1953)

Tables

• groups key now works in Tables. 🟡 Low (NE-1866)
• pass-through columns are handled differently, and carry columns now appear differently in the summary sections of tables. ⚪ None (NE-1867, NE-1868)
• Table output is now HTML-sanitized. ⚪ None (NE-1930)
• Removed the "Go to Reports" button from the Table page. ⚪ None (NE-1864)

Data Explorer

Data Explorer has been updated, and links that previously opened the Data Viewer now open Data Explorer with the Data tab active. Plots no longer shrink in Data Explorer. ⚪ None (NE-1928, NE-1908, NE-1942)

Workflows and Executions

Archive and restore executions — 🟡 Low

Executions can now be archived. Archived executions can be shown and restored (un-archived) from the UI. (NE-1841, NE-1842)

Execution reliability — 🔴 Medium

Fixed executions failing on an account due to context leakage between executions. (NE-1943)
Related hardening: review of caching contexts (🟡 Low, NE-1947), and of Execution, Workflow and Task ID handling (🟡 Low, NE-1929).

Workflow status and error handling — 🟡 Low

• Non-fatal item failures now follow the fail-fast cascade as intended ("succeeded with issues"). (NE-1870)
• Fixed RuleExceptionMode handling for Data Cleaning in multi-step workflows. (NE-1874)
• Fixed "Unknown Dataset" being shown on child executions. (NE-1886)
• The error message for duplicate records found for a profile is now more informative. (NE-1853)

Diagnostics, Warnings and Issues — ⚪ None

Issues/Warnings colors and legend updated; diagnostics error information, including statusCode: 6, now renders correctly; warnings and issues from earlier steps no longer appear in all later steps; Validations warnings can be suppressed; API status now includes sub-categories (info, warnings, issues). (NE-1935, 1892, 1887, 1899, 1891, 1791)

Data Cleaning

• Data Cleaning History is now visible to all users. ⚪ None (NE-1934)
• Rules now accept new columns. ⚪ None (NE-1903)
• Rules with sub-rules support schema migrations and version validation. ⚪ None (NE-1774)
• Input and output file names now appear in the execution summary. ⚪ None (NE-1856)

Reports

• A clear error is now shown when no report template is selected. ⚪ None (NE-1933)
• Drag-and-drop scrolling in the Custom Reports editor is improved. ⚪ None (NE-1772)
• Templates are now cached for faster loading. ⚪ None (NE-1787)

Administration, Validation and Security

Audit Logs in the administrator area — 🔴 Medium

Fixed a defect where tenants and users could not be selected in the Audit Logs viewer. (NE-1851)
Suggested check: confirm audit log filtering by tenant and user.

User creation — 🔴 Medium

Fixed an error when creating users. (NE-1835)

Validation History — 🟡 Low

The "Download package" button on the Validation History page now works. (NE-1837)
Also: the Start Validation button text is fixed, and validation input data and warning handling are improved. ⚪ None (NE-1940, 1893, 1888)

Other fixes — ⚪ None

User messages now work (NE-1836). All download buttons show a loading indicator (NE-1813). Large file streaming error fixed (NE-1906). Execution input file name and size are updated (NE-1810).

API and Developer

• OpenAPI/Swagger documentation added, with the auth security scheme, servers and operationIds. The docs site is deployed and the SDK is generated from the spec. ⚪ None (NE-1613, 1846, 1845, 1849, 1848)
• Postman collection and integration tests updated. ⚪ None (NE-1850)

GxP Impact Summary

🔴 Medium (8)

Ticket	Area	Summary
NE-1896	Calculations	Full output missing when KEL cannot be calculated
NE-1852	Calculations / Export	Full results not exported for combined single-dose and steady-state analyses
NE-1840	Calculations	No PK fitting results for models with tlag
NE-1855	Engine	Refactor paramcd registry
NE-1854	Engine	paramcd registration consolidation
NE-1943	Executions	Executions failing due to context leakage
NE-1851	Administration	Audit Logs: unable to select tenants or users
NE-1835	Administration	User creation error

🟡 Low (13)

Ticket	Area	Summary
NE-1947	Executions	Hardening: caching contexts and context leakage
NE-1929	Executions	Hardening: Execution / Workflow / Task IDs
NE-1886	Executions	Unknown Dataset on child executions
NE-1874	Data Cleaning	RuleExceptionMode in multi-step workflows
NE-1870	Workflows	"Succeeded with issues" bypassed the fail-fast cascade
NE-1866	Tables	groups key not working
NE-1853	Calculations	Uninformative duplicate-records error
NE-1842	Executions	Restore archived executions
NE-1841	Executions	Show archived executions
NE-1837	Validation	Download package button not working
NE-1831	Calculations	Use a column as the conversion value
NE-1712, NE-1711, NE-1709	Plots	Plot Themes: plotting engine, data storage, API

⚪ None (57)

UI, documentation, test and deployment items. The full list is available on request.

Impact ratings reflect Aplos's assessment against typical regulated use. Customers remain responsible for assessing each release against their own configuration and intended use.

Updates to PK Model Fitting

Revised sequencing of PK model fitting to run faster. Added ability to enable/disable PK model fitting from the PK analysis configuration page. Default setting is PK model fitting is disabled.  

New Data Cleaning Rule: Count records

New rule in Data Cleaning to count number of records based on a set of grouping variables. This can be used to identify profiles that do not have adequate samples for PK analysis in a large dataset. 

Updates to AUCtau calculation

AUCtau was only be calculated when a terminal elimination rate constant could be estimated. The calculation was updated to be calculated if data is available for the full tau interval regardless of ability to estimate the terminal slope, or extrapolated to the full interval using the terminal slope.

Partial AUC name detection

If the user provides a paramcd value that matches an existing paramcd name, the text will be updated so that it has a unique name. For example, if the user provides "Cmax" for the paramcd name it will be modified to "custom_Cmax" to distinguish it from the "Cmax" variable.

Data Cleaning History page added

Users can now view previous data cleaning actions from the Data Cleaning History tab on the Input Data page. Future updates are coming in this area to support other exploratory analyses.

Updates for SSO login support

Updates to support SSO login were made. These will only be visible to organizations that have implemented SSO. 

Bug fixes

Minor bugs fixes to the user interface to disable buttons when executions are in progress, enable validation package download button. Bug in final results file preparation that excluded some individual parameters was fixed and better error handling for datasets with duplicate samples.

Performance updates to Analysis History Page

Speeds up loading of prior analyses and related steps in the user interface. Allows faster launching of re-analysis steps. 

Update user roles

User roles (user vs administrator) now handled with a single source of truth. 

Added Grouping Variables to Ratio Calculations

Grouping variables can now be added to the Ratio calculation in Custom Calculations. This allows you to calculate the same parameter across multiple groups. For example, you can now calculate a dose-normalized partial AUC across both fed and fasted treatments for the same subject with a single ratio calculation call.

Custom Report Templates

Users can now upload customized report templates for use with Aplos NCA Reporting feature. All templates are versioned. Users can upload templates for their own use. Administrators can upload templates for use across the organization. A sample template file is provided for use.

Added Best Fit Terminal Slope Replacement

Users can now replace the automated "best-fit" terminal slope with a different terminal slope of their selection in the Custom Calculation engine. 

Bug Fix: All concentrations are missing

Fixed bug that caused failure when a subject had all missing concentration values. Now profile will have all results reported as "Not Determined" (ND). 

Added Duplicate button

Users can now duplicate any object in Data Cleaning, Custom Calculations, Plots, and Tables. This creates an identical object with a new description. All selections of the duplicated object are carried to the new object. 

Added Series Selection to Plots

Users can now select different series to group and color plots. For example, if you have multiple study days and multiple dose levels, you can group data by Study Day and Dose, but only color by Dose. 

Added Non-Linear Model Fitting

Non-linear model fitting results will be provided for all single-dose profiles. IV bolus and IV infusion administration will be fit to 1-compartment, 2-compartment and 3-compartment PK models. For the extravascular route, the same compartment models will be tested with and without a lag time (6 models in total). The preferred model will be identified by the lowest AIC and lowest BIC values for all models. Parameter estimates will be provided for all models as will observed and predicted concentrations. 

Updated Error Handling in the Post Processing Step

When generating tables and plots during post-processing, a failed table or plot will not result in a complete failure of the entire step. Instead, a diagnostic file will be provided that gives an error message on why the specific plot or table failed. Other plots and tables will be produced. 

Added Folders to Analysis History

Users can now move analyses to folders to organize their results. Users can add, rename, and delete folders. Analyses can be moved from one folder to another. If a folder is deleted, analyses within that folder are returned to the "No folder" area. Analyses are never deleted.

Added Data Manipulation Functions to Custom Calculations

Users can now manipulate results file to add columns and perform other actions to support production of tables and plots. Many of these data manipulation functions are derived from the Data Cleaning tool.

Upgrade to Version 3

Entire system has been updated to version 3 of Aplos NCA for all users. This includes an updated analysis process that provides stepwise analyses from data cleaning to PK analysis to custom calculations to plots and tables to reports. Both the backend systems and frontend website have been updated.

Custom calculations, plots, tables and report now available in the User Interface

Users can now perform custom calculations (i.e. relative bioavailability), create plots and tables, and generate reports in Microsoft Word format directly from the web user interface. 

Support for related objects

Aplos NCA now supports related objects. Data manipulations that result in a new file will now be linked to the original input file. Custom calculations, plots, tables, and reports will be linked to preceding steps to ensure full traceability for all analyses.

and much, much more!

 

 

No more analysis limits

Analysis limits have been removed. Based on user feedback, we have removed all analysis limits. The dashboard will now show the number of completed and failed analyses for each individual user. We will monitor usage and may throttle users that are conducting a high volume of analyses in a short period of time (e.g. 30 analyses in less than 10 minutes). This protects against potential infinite loops of repetitive analyses that may cause a drain on computing resources for other users.

Support for CSV files in UTF-8 format

Aplos NCA now supports comma-separated variable (CSV) files saved in UTF-8 format. UTF-8 is an encoding system that supports more characters from multiple languages. Recently Microsoft Excel changed to UTF-8 format as the default for CSV files. These files are now accepted and converted into ASCII encoded files for processing. The converted and original file are available in all analysis downloads. 

Improved error messages

Error messages have been improved to provide more information to the user when errors are encountered.

 

 

Data Cleaning user interface

The user interface was added to enable users to create the data cleaning JSON from the user interface. Users can select the data cleaning rules, enter the required information and then process the data for cleaning. This includes creation of complex data cleaning rules like BLQ handling with just a few questions.

Updates to Input Data page

Users have many new options from the input data page. These include the ability to select data for cleaning, view the data in tabular format, download the input data file, and archive the data file. 

Improved error messages

Error messages have been improved to provide more information to the user when errors are encountered.

Additional filtering options for Analysis History page

Users can now limit the analysis history page to selected time windows to make it easier to find the analysis of interest. Users can select last 7 days, 30 days, 90 days, 365 days, or set custom start and stop dates to filter the data.

Coming soon: Parallel processing

We are making big changes in how we process analyses in the coming months. Currently, each unique PK profile is processed in sequential fashion. We are working to create parallel processing for profiles so groups of 5-10 profiles are processed in parallel with each other. This should provide significant performance advantages for large datasets including simulations. Watch for updates in the coming weeks and months.

 

Addition of new terminal rate constant methods

Users can now select one of 3 different methods for determining the terminal rate constant. Details of the 3 method are provided in the documentation at https://docs.aplosanalytics.com/docs/methods/terminalslope.html . Briefly, method 1 uses all samples from Cmax to Clast and then from Cmax to the point before Clast to estimate terminal slopes with 3 or more samples. Method 2 is identical to method 1, except Cmax is not included. And Method 3 uses all samples from the point after Cmax to Clast. The last method closely matches what other software package perform in automated selections. 

Addition of post-analysis calculations

Users can now include custom post-analysis calculations with Aplos NCA. This allows user to specify calculating additional parameters after the NCA parameters are calculated. Examples include calculating metabolite ratios of AUCs, accumulation ratios with Cmax or AUC, and more. The user can specify the calculation and the parameters to use in that calculation. Details are provided in the documentation at https://docs.aplosanalytics.com/docs/methods/post-processing-json.html . This feature is in beta and requires preparation of JSON file for operation. A user interface will be developed in the coming months.

Addition of custom tables

Users can now perform custom table generation with Aplos NCA. The table output can be created from the analysis results. This includes individual parameter tables, summary parameter tables, and combined individual and summary parameter tables. Details are provided in the documentation at https://docs.aplosanalytics.com/docs/methods/post-processing-json.html . This feature is in beta and requires preparation of JSON file for operation. A user interface will be developed in the coming months.

Addition of custom plots

Users can now perform custom plot generation with Aplos NCA. The plots can be created from the input data or the analysis results files. This includes individual and summary data for plots and full control over all aspects of the plots including symbols, lines, colors, axis breaks, axis labels, and more. Details are provided in the documentation at https://docs.aplosanalytics.com/docs/methods/post-processing-json.html . This feature is in beta and requires preparation of JSON file for operation. A user interface will be developed in the coming months.

Addition of custom reports

Users can now generate custom reports with Aplos NCA. The reports can leverage user templates in Microsoft Word format and permits insertion of tables and figures with captions and footnotes. Details are provided in the documentation at https://docs.aplosanalytics.com/docs/methods/post-processing-json.html . This feature is in beta and requires preparation of JSON file for operation. A user interface will be developed in the coming months.

User interface improvements

Several improvements were made to the user interface to address performance and aesthetics. The color scheme was revised slightly to provide a more seamless experience with all parts visible in both light and dark modes.

Other bugs and improvements

If concentrations are increasing and thus the terminal rate constant is negative, it is excluded from the best-fit selection algorithm. These values are reported in the individual results file for the user. If measured concentrations are available, but the dose amount is zero (i.e. placebo treatment), the dose-adjusted PK parameters are  now reported as not determined (ND).

Performance improvements to web app

Significant performance improvements were made to the web app. Analysis history, input data, and validation history pages load much faster. The user interface is more responsive during execution of analyses, with updates every 1-2 seconds. Minor updates to the user interface were also implemented to streamline the display of information for the user.

Ability to select desired output

Users now have the ability to turn on/off specific types of output including individual plots, summary plots, summary tables, and the technical report. By default, these outputs are “on” and will be produced. If they are not needed, users can turn them off individually in the configuration. This may be useful when a user only needs the calculated parameters and does not need the other outputs for their analysis. If a user wants the outputs at a later date, they can re-run the analysis and turn the desired outputs back “on”.

Addition of messages

Messages from Aplos to users are now visible on both the login page and in the header after login. These messages include notices about new features, upcoming license renewals, and other important information from Aplos.

Complete configuration JSON added to documentation

Documentation has been updated to include a complete configuration JSON file that includes all possible configuration settings. Users can download and use this template to develop their own configuration JSON files to support analysis submissions directly to the API through platforms such as SAS, R, Python, and others. In addition, these JSON files can be copied into the user interface for analysis.

Bug fixes and other minor modifications

Small bug fixes were addressed in the administration module related to the changes by users to their profiles and/or access rights. Color theme was consolidated across the web application for a more consistent feel to the app. Updates to web app to eliminate incorrect error messages when uploading input data files that are not in CSV format. Improved error handling when a subject has no measurable concentrations in a profile.

Analyze single dose and steady-state data at the same time

Users can now analyze single dose and steady-state data in a single analysis by using a data column to define the dosing frequency. The selected column should contain “single” if the data is associated with a single dose, or “steady-state” if the data is associated with a steady-state dose. Aplos NCA will read the first record for each unique profile and then use that information to calculate either single dose or steady-state parameters.

Analyze data from different routes of administration at the same time

Users can now analyze data from different routes of administration in a single analysis by using a data column to define the type of dose. The selected column should contain “ev” if the dose is extravascular, “iv-bolus” if the dose is an IV bolus, and “iv-infusion” if the dose is an IV infusion. Other relevant information about the dosing method should be provided. For example, if IV infusion is one of the dosing methods, either the duration or rate of input should be provided. Those values will be ignored for routes of administration for which they are not relevant.

Partial AUC user interface updated

The user interface has been updated to accept underscore (_) symbol in the parameter code column. This allows users to enter a value such as “pAUC0_2” to represent the partial AUC from 0 to 2 hours.

Minor bugs and fixes

Small updates to the user interface for managing users (administrators only), handling subscriptions properly, and managing validation runs were completed.

Partial AUC calculations

Users can now define partial AUC values for calculation during analysis. Users can specify the start and stop time for each partial AUC to be calculated. Users also specify the parameter name (e.g. “Partial AUC0-4hr”) and parameter code (e.g. “pAUC04”) to be included in the output files. Users can specify as many partial AUC values as needed.

Exclusion column

Users can now define a column for data record exclusions from the analysis. Users define a column name and then the exclusion code in the configuration. Any record in the data that matches the exclusion code in the exclusion column will be excluded prior to analysis.

Download files from failed analyses

Users can now download configuration and data files from failed analyses. This can be useful to diagnose errors in the configuration file or analysis dataset.

Kel rules UI updated

The Kel rules section of the user interface was updated to provide user feedback when invalid entries are included for the various rules. For example, the minimum statistic value must be a decimal number between 0 and 1. If a value outside of that range is entered, the user interface displays a reminder to the user to update the value.

Minor bug fixes

Small updates to the user interface to give feedback on proper selection of grouping variables. Removal of sorting input from user interface as it is generally not needed. Improved error capture and inclusion of text file documenting non-fatal errors in the output (e.g. missing dose information that prevents calculation of dose-normalized parameters). Improved handling of very small numbers (e.g 1e-6) in output. Improved handing of grouping variables for sparse data analysis.

Added ability to analyze sparse data

Analysis of sparse data is important to support toxicokinetic studies, commonly with smaller species such as mice and rats. When a complete PK profile is not possible for each animal, a composite profile is constructed from multiple animals at each time point. The ability to analyze sparse data has been added to Aplos NCA. Simple select the “Sparse Data” option on the Dosing screen. Select all other settings as you normally would, and be sure that you include all appropriate grouping variables for the analysis (e.g. sex, dose). Aplos NCA will calculate the mean concentration-time profile for each unique set of grouping variables, and then will calculate the PK parameters for each composite profile.

Summary concentration values are exported

The mean and standard deviation values for the summary concentration-time plots are now available in the export package. These concentration-time data are included as CSV files in the /plots directory of the analysis output.

Integration testing added

Integration tests are automated tests that simulate a user working with the Aplos NCA software. Actions such as uploading a file, initiating an analysis, downloading results, and logging into the system, can be automated using integration tests. These tests are performed prior to releasing the software after an upgrade. By automating these tests, we can evaluate more features before any version is released to the production servers. This minimizes the risk that a software update will cause problems in another part of the application. While this is invisible to users, it is critical to allow us to deliver monthly updates to our software in a robust and reliable way. It also reduces the amount of manual testing we need to perform which can shrink the time between completing a feature and making it available to users.

Bug fixes and minor changes

Resolve an issue with uploading Excel (xlsx, xls) files by restoring a library. Resolved issue with AUC_tau calculations when samples below the limit of quantitation are observed at steady state. Swapped location of the “Unique ID” and “Time” columns in the user interface. Resolved issue when profile has no measurable observations.

User management features added

User management features for team and enterprise accounts has been added. Administrators can now add, update, and disable users for their team and enterprise accounts using the web interface or the API.

Dashboard metrics updated

The dashboard metrics were updated for team and enterprise accounts to show the allocation and available analyses for the entire team. Individual user metrics for number of completed and failed analyses are still displayed. Also updated the displayed number of available analyses to account for any analyses currently “in flight”.

Search features added

Search boxes are available on the input data, analysis history, and user management (administrators only) pages. Users can search by filename, date, meta data, username, or other aspects of the input file, analysis, or user. Results are automatically filtered to any matching information in the list. Useful for rapidly locating a previously uploaded file or previously conducted analysis.

Updated guided tours

Updated guided tours were added to multiple pages on the Aplos NCA website. Using the “Need Help?” button on the lower left of the screen, relevant guided tours for the currently visible page are shown. These tours show you how to upload data, initiate an analysis, use the data explorer, conduct a validation, download results, and more.

Increased responsiveness of website

The website is more performant when executing an analysis. The progress of each analysis is updated every 2 seconds, whether the analysis is started from the web interface, or via submission directly through the API.

Other bug fixes

Several small bug fixes resolved issues with using some text variables for grouping, listing the company name in the technical report, and generating more informative error messages on the website.

Validation added to the Aplos NCA API and Web Interface

Users can now initiate a new validation or download results of previously executed validations. The validation initiates Aplos NCA to calculate PK parameters for 6 different input datasets that are stored on a public repository. These are: (1) single dose extravascular, (2) single dose IV bolus, (3) single dose IV infusion, (4) steady-state extravascular, (5) steady-state IV bolus, and (6) steady-state IV infusion. The calculated results are compared to the known results available from that same public repository. The validation passes if all results from all 6 datasets matches the known results exactly. The validation fails if any calculate parameters are different. The validation results include both a validation report and the 6 individual analysis packages with comparisons.

Aplos NCA Web Interface page loading times improved

Webpage loading times for the input data, analysis history and validations pages have been significantly improved.

User metrics updated

User metrics on the dashboard page have been updated to reflect the number of available analyses for a user. The time required to load the metrics has been significantly improved.

Load configuration for new analysis feature updated

The button to load a previous configuration using a prior version of the Aplos NCA engine has been improved. Analyses that used columns as inputs (e.g. for dose amount) now correctly load for a new analysis.