The Edge Software Consultancy

DMPK

Drug Metabolism and Pharmacokinetics

 

Overview

 
 
Glucose concentration analysis in Morphit during a PK Study

Glucose concentration analysis in Morphit during a PK Study

Data analysis templates

The DMPK collection of Morphit binders are designed to address the data analysis needs of DMPK scientists. They provide support to:

  • Read raw data files from instruments such as Mass Spectrometers

  • Identify and analyse the peak area data, applying statistics and curve fitting

  • Calculate and visualize end point results

  • Apply quality control (QC) criteria

  • Prepare data for storage in BioRails DM with graphs and charts

Each binder covers a large range of different conditions, such as different species, starting concentrations, cofactors, etc. The collection includes assays such as: Binding, Clearance, Stability, Interaction (CYP induction and inhibition), Partitioning, Solubility, Permeability, hERG, and noncompartmental analysis for PK.

See demonstration videos…


Planning

A critical part of any DMPK study is to arrange samples on a plate in order to both conduct the assay on automation equipment and also for injecting the samples into the Mass Spectrometer for determination of drug or substrate concentration. The arrangement of samples on the plate must both reflect the process of creating the plate and the need to efficiently process samples without the need for extended run times on the instrument. Morphit (part of the BioRails DM module) offers two tools for this:

  1. Sample Plate Assignment - allows scientists to drag and drop samples onto a plate to establish a pattern which can be systematically applied to further samples and future sample sets.

  2. Injection list editor - the order samples are injected into the Mass Spectrometer column is critical to analysis. This component allows scientists to arrange the samples, duplicate injections and adjust to operational needs.

DMPK is a dynamic environment with a high demand for efficiency and ever faster turn around times. BioRailsDM offers scientists from both pharmaceutical, biopharmaceutical and CROs the tools they need to meet these demands.

Samples can be arranged onto analysis plates ready for the mass spectrometer

Samples can be arranged onto analysis plates ready for the mass spectrometer


Study report generated from Morphit

Study report generated from Morphit

Reporting

DMPK is a crucial part of any drug discovery and development effort. Demand for these services can be rate determining to program efforts. Compilation and interpretation of results for consumption by project teams demands clear and concise reporting formats that often take a lot of manual effort to create. BioRails DM offers template reports that, once set up, automate the majority of the reporting effort including:

  • Combining results from different assays

  • Present graphs and charts of summarised results

  • Automatically include protocol information as well as observations from the study

  • Reduce the burden on scientists to compile routine reports

High quality reports can be generated in PDF, Word or Excel format.