 Kinetica
Bioinformatics
Gold: Kinetica, Thermo Fisher Scientific |
From non-compartmental through to population pharmacokinetic-pharmacodynamic
analyses, Thermo Electron's Kinetica facilitates data analysis and
reporting in a flexible environment. Kinetica offers fast high-throughput
data analysis for clinical, preclinical, discovery, drug metabolism
and drug delivery settings. Kinetica improves your data analysis
experience while reducing the need for multiple software packages
and associated training.
Kinetica provides a broad collection of tools to meet the needs of scientists
engaged in various disciplines, from bioanalytical laboratory to clinical
trials. Kinetica is also the analytical engine within Thermo's Enterprise
Pharmacology Series, a powerful pharmacokinetic-pharmacodynamic data management,
analysis, simulation, database and reporting solution.
With an intuitive point-and-click graphical interface, Kinetica facilitates
data analysis and reporting in a flexible, easy-to-learn environment. A
unique non-compartmental assistant technology and a multitude of different
standard and advanced PK, PD and PK-PD models offer the best in high-throughput
data analysis. Import your data or create datasets, select and tailor your
computational methodologies, view your data with dynamic graphical tools,
view individual and study results in an organized fashion, export your
result through the seamless interface to other software.
Designed as a template-driven system, Kinetica allows you to create predefined
templates and analysis settings. The template format allows high-throughput
analysis and customized automation to standardize analyses based on company
SOP and guidelines; the same format can be applied to any other studies
thereby offering standardization across your organization. The advantages
for your company are high consistency between analyses and between users,
time savings in not having to put efforts in validating each user's analysis,
and version control between analyses of the same study.
With the seamless interface with Thermo's Watson bioanalytical LIMS, Kinetica
brings you fast and rapid analysis and report so you do not need to spend
time moving data from software to another. Built as a single solution for
non-compartmental, standard compartmental, population pharmacokinetic analyses,
bioequivalence, graphing and reporting, Kinetica again saves you time transferring
and formatting data.
Non-compartmental Analysis (NCA)
The innovative NCA assistant allows rapid view of the analysis via a graphical
point-and-click interface. Kinetica recognizes flagged data for below
limit of quantification, outlier, error and missing to allow user to
specify the handling of flagged data during the analysis without sacrificing
the data themselves.
Unit Management
With a powerful unit management tool, user can specify the output pharmacokinetic
parameter units as well as input time and concentration units from an
extensive list of measurement units. Versatile unit conversions are built
into the tool for molar conversion.
Data Exchange and Storage
Ever have the experience of not finding your analyses from years back when
drug filing is coming close? Kinetica gives you the simple single file
storage so you no longer need to save your analysis into many separate
files. All data and analysis information are stored in a single file,
including method information, algorithms, graphs and reporting set-up.
The Import Assistant provides an easy import of row- and column-based
data from Microsoft Excel, ASCII files and direct ODBC-compliant data sources.
It also includes support for direct Oracle database import from the Watson
bioanalytical LIMS system. In addition, your data and analysis results
can be exported to ASCII, Microsoft Word or Excel.
The Table Assistant comes with predefined table structures for all your
reporting needs. Table structure templates include preclinical, clinical,
toxicokinetic, sparse study designs. The tool allows you to preset the
number of significant digits or decimal points for your data and results.
Kinetica for Population PK/PD Analysis
Even if you have NONMEM, Kinetica population analysis will compliment your
NONMEM experience by providing accurate initial estimates so that your
NONMEM analysis runs smoothly. Kinetica's robust population analysis
module gives you fast and accurate results. The system includes a powerful
multi-dimensional search option to identify relationships between the
model parameters and available covariable.
Kinetica incorporates the EM algorithm that was originally in P-Pharm.
The population estimation algorithm in Kinetica is an iterative process
that computes the maximum likelihood estimates. It also allows the user
to incorporate covariable model and to check for the decrease in interindividual
variability of the parameter estimates after taking the covariable model
into account.
Kinetica also allows the user to perform both external and internal validation
of the population model. The user can apply the existing population model
to a new dataset from another study (external validation) or the user can
split the data into either the test set or the validation data set (internal
validation). Kinetica uses two methods to validate population models, namely
(1) Prediction errors on concentration method (or concentration method)
and (2) validation through parameter method (or parameter method). The
concentration method uses the parameter values from the test dataset to
predict the concentration for individuals in the validation dataset group.
In the parameter method, model parameters are predicted from the validation
data set with or without covariates; bias and precision are calculated
for the predictions.
Data Analysis
Kinetica includes more than 60 different validated templates, including
non-compartmental, PK, PD and PK-PD fitting for standard compartmental
and population analyses, absorption, convolution, deconvolution, renal,
protein binding, enzyme kinetics, transdermal, in-vivo and in-vitro correlation,
and in-vitro dissolution. It comes with an extensive library of data
analysis methods.
The Kinetica Basic scripting language is a subset of Microsoft Visual
Basic Applications that allows user to build custom workflow, analysis
settings, data import, data handling and reporting. Kinetica also comes
with a Visual model designer for users to create multiple compartment models
which automatically create the Kinetica Basic code that represents the
visual model.
Testing Agent
The Automated Test Agent performs a complete comparison of the calculations
of Kinetica as it is installed on your system with reference analysis
outputs that were generated in Thermo's QA environment. Test Agent would
help with IQ and perhaps a part of OQ, as it is a basic check that the
software is installed and calculating correctly in your environment.
The second stage involves testing the features of the software to ensure
they are performing as intended. |
