ToxKin

Standard Toxicokinetic
and Pharmacokintetic Evaluation

ToxKin is a fully GxP and FDA 21 CFR Part 11 compliant, validated 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 flexible creation of toxicokinetic reports for standard studies within the shortest time, while also providing sufficient flexibility for specialized analysis and reporting.

Overview of Key Features

Regulatory compliance

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

Direct data import

• Direct data import from KinLims, Watson or PhaLIMS

• Import wizard with data mapping

Configurable study design

• Master data settings for administration routes, species, unit categories and conversions factors

• Single-dose, multiple-dose or continuous dosing study designs with different substances and active entities

• Flexible grouping of data batches

• Different configurations of analyte matrix routes (AMR) and concentration values supported

• Large predefined set of statistical TK and PK parameters

• Configurable set of statistics, parameters and reports for each evaluation design 

• Extensive search capabilities for study entities in dedicated views

Explorative Evaluation

• Interactive user interface for explorative evaluations

• Definition of LLOQ rules

• Individual and nominal time and dosing

• Individual as well as composite subject profiles

• Regression lines and points of concavity per profile

• Exclusion and inclusion of single values

• Manual or automatic exclusions for profiles

Comprehensive evaluation parameters

• Descriptive statistics:
  N, mean, CV, SD, SE, median, range; gN, gmean, gSD, gSE, gCV

• Wide range of predefined TK and PK parameters:
  AUC (with intervals and extrapolation rules), mean residence time (MRT), clearance measurable from the matrix, volume of distribution at steady state and in pseudo distribution equilibrium, Peak-Trough-Fluctuation, Half-Life

• Calculation of nominal and dose-normalized values

• 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

• Template editor for user-specific reports

• Export of ready-to-publish reports
  in different formats

Full traceability and transparency

• Audit trail with human readable reports

• Complete object history and full log of user actions

• Electronic signatures configurable

• 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

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