ToxKin

Mission

ToxKin is an innovative, server-client software solution for the non-compartmental analysis of toxicokinetic and pharmacokinetic studies. From the study design to the final report, ToxKin is designed to support routine evaluations and rapid creation of toxicokinetic reports for standard studies, while also providing sufficient flexibility for specialized analyses and reporting.

Benefits

1. Rapid standard reports: More than 50 TK/PK parameters, 12 built-in statistics calculated per parameter and 46 configurable report types for comprehensive reports in no time.

2. Reusable designs: Centralized and validated solution supports collaboration and reusability of evaluation settings and report designs via templates.

3. Regulatory compliant: 21 CFR Part 11/GxP compliant with electronic signatures and audit trails.

What is new?

The current release contains numerous changes including:

  • Landscape format for all reports
  • New wizard for study creation
  • Support for Bark LIMS
  • New interval unit “period”
  • Selectable unit for all time parameters
  • Configurable parameter names...

 

Contact us for more information about Entimo's products, release information and roadmaps.

ToxKin Highlights

Regulatory compliance

  • Fully compliant with FDA 21 CFR Part 11 and ICH GxP regulations

Direct data import

  • Direct and seamless data import from Watson, CCW, KinLims, PhaLIMS and Excel
  • Wizard for master data mapping, import branch selection and grouping settings

Study templates

  • Template editor for reusable evaluation designs
  • All statistics, parameters and report properties pre-configurable in a template

Configurable study design

  • Master data settings for administration routes, species, unit categories and conversions factors
  • Study designs with single dosing, multiple constant and multiple variable dosing with different analytes, matrices, routes in one study supported
  • Flexible grouping of data batches
  • Selection of different LLOQ rules and extrapolation rules for missing values

Explorative Evaluation

  • Interactive user interface for explorative evaluations
  • Individual and nominal time and dosing
  • Automatically calculated composite profiles
  • Linear, logarithmic and linlog trapezoidale rules for AUC calculation
  • Up to 6 regression lines per profile
  • Points of concavity
  • Exclusion of single values
  • Manual or automatic exclusions of profiles
  • Unit conversion

 

Comprehensive evaluation parameters

  • Arithmetic and geometric descriptive statistics: N, mean, CV, SD, SE, median, range; gN, gmean, gSD, gSE, gCV
  • Wide range of predefined TK and PK parameters (small selection): time and concentration parameters and ratios including MRT, AUC, AUMC, clearance, volume of distribution, peak-trough fluctuation...
  • Bioavailability, metabolyte and accumulation ratios, linearity factor
  • Terminal half-life and regression parameters
  • Calculation of normalized values (dose, weight, body surface factor)
  • Computation of male to female and day N to day 1 ratios

Powerful and flexible reporting

  • Rapid creation of standard reports from templates with predefined elements
  • Report generator for individual selection and configuration of report elements
  • Flexible arrangement of report parts
  • Export of ready-to-publish reports in different formats (PDF, MS Word, HTML)

Full traceability and transparency

  • Audit trail with human readable reports
  • Complete object history and full log of user actions
  • Electronic signatures
  • Support of independent brunches and versions
  • Status-based workflow for study data

Online adminstration

  • Easy role-based access right definition
  • Online system configuration


     Download the factsheet: ToxKin