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ToxKinTM

3 reasons for ToxKin:

1. Rapid standard reports: More than 50 TK/PK parameters, 12 built-in descriptive 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:
ToxKin fulfils regulatory requirements and is 21 CFR Part 11/GxP compliant with electronic signatures, audit trails, date/time and
user stamps.

 

 

Rapid Reporting for Standard Toxicokinetic
and Pharmacokintetic Evaluations

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.

Overview of Key Features

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

Further Info

Download fact sheet

Request info more about entimICE ToxKin here...

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