Debra

Metabolism LIMS

By managing the data electronically, Debra significantly improves workflow efficiency in the following areas:

• Direct capture from equipment, thus eliminating transcription errors.
• Easy to use batch worksheets to organise data capture.
• Automatic calculations of dosing requirements.
• Immediate generation of raw data and summary reports.
• Easy label generation for all samples.
• Direct links with the industry standard Laura radiochromatography and Seescan WBA software.
• Automatic calculation of results.
• Audit Trail.
• Security Access in accordance with regulatory requirements.
• Electronic signatures; no more missing manual signatures.

Debra is a closed system that ensures compliance with regulatory demands.

• User access is managed via a unique login ID and password that is linked to users’ training and skill set.
• Electronic signatures and audit trails are fully configurable and in line with the FDA 21 CFR part 11 requirements.
• Debra has full auditing capabilities to ensure that any changes are fully tracked and easily reportable.

LabLogic have decades of experience creating systems within highly regulated environments. We are confident that our systems will improve compliance within your facility.

From single user labs through multi-site global organisations, Debra streamlines processes and workflow with modern intuitive software. Originally designed for simple ADME mass balance and tissue distribution studies, the range and complexity of protocol handled by Debra has been extended covering all aspects of DMPK work including bioanalytical, metabolite profiling and protein binding, as well as environmental fate studies.

To achieve the goals of productivity and GLP confidence, Debra avoids transcription errors by capturing raw data either directly from the instrument or via sample result data files from analytical instrumentation systems.

• No transcription necessary.
• Seamless communication to and from the instrument.
• A wide variety of models and versions of balances, LSC’s and WBA are handled with
  instrument specific interfaces.

• Create simple or complex protocols to suit your needs.
• Easily add subjects and apply naming masks.  
• Group subjects by species, sex, dose level, dose rate.
• Configure single or multi dosing schedules per project, group or subject.
• Easily configure sampling schedules.
• Assign users to the study based on their access rights.

• Design, prepare and analyse dose preparations, dose vehicles and stock solutions.
• Manually enter existing treatment data or interactively create new treatments.
• Automatically calculate dose compound requirements accounting for compound properties.
• Directly capture preparation weights and analysis data.
• Automatically calculate treatment concentration and specific activity.

• Automatically perform dose calculations based on treatment data and nominal dose rate.
• Design dosing schedule ahead of time.
• Directly capture subject and dose weights either separately or as a single process.
• Create multi-dose studies.
• Capture the actual time of dosing to calculate real-time sampling for PK studies.
• Immediate calculation of compound and activity administered.

• Directly capture weight data from balances.
• Eliminate transcription errors; no manual entry or data checking required.
• Interface with LSCs to import dpm data.
• Design and print sample labels.
• Create scheduled or barcoded batches for data capture.
• Automatic detection of manual data entry, with full audit trail.
• Immediately generate reports following data capture.

• Pool samples across subjects or timepoints to create new samples for analysis.
• Specify percentage of original sample to split, or use a fixed amount.
• Automatically specify samples to be pooled based on dose recovery.
• Optionally capture pooled sample data, or use calculated values.

• Direct link to our industry standard radiochromatography software, Laura.
• Create HPLC batches within Debra ready to run your analyses in Laura.
• View chromatography data in Debra for each sample; calculate and report metabolite concentrations and dose recovery.
• Link security between the two systems.

Calculate recoveries and concentrations taking into account parameters such as:

• Multi-dose settings.
• Blood : Plasma ratios.
• Variability rules.
• LOD / LOQ settings.
• Tolerances.
• Normalisation settings.

Go from raw data to final results in minutes. A wide range of reports is available, covering all functional areas of the system.

• Raw data reports.
• Summary tables for final recovery and concentration reporting.
• Instant graphical data to track sample recovery and concentration.
• Tissue grouping.
• Configurable decimal and significant figures.
• Statistical analysis.
• Normalisation of data.
• LOD and LOQ reporting rules.
• Include/exclude subjects, tissues and timepoints.

• Generate project specific labels based on data entered into the system with just a few clicks.
• Highly configurable user-defined formats.
• Predefined label formats can be created to cover the corporate standard.
• Barcoded labels allow the user to take advantage of barcoding options for data collection to speed up processes within the laboratory and reduce the risk of user error.

Regulatory compliance is an essential feature of Debra, built to meet GLP, and 21 CFR part 11 requirements.

Electronic Signatures

• Fully configurable for all tasks.
• Options for:
  Single signatures.
  Double signatures for peer approval.
  Silent signatures where no action is required by the user to apply the signature.
  Disabled signatures.

Debra’s electronic signatures are in line with regulatory guidance to ensure that relevant details are captured:

• Printed name of the signer.
• Date and time that the signature was executed.
• The meaning associated with the signature (e.g. authorship, review, approval etc).

Audit Trail

• Debra provides full auditing facilities. This ensures that changes to date are tracked with reference to the new and previous value, the operator and date / time.

User Settings

• Quickly and simply configure user access and rights.

Access Levels

• Configure hierarchical levels of access.

Screen Controls

• Fully configure access to every control within Debra based on access level.

Debra’s reporting package provides convenience and flexibility. Using the comprehensive range of reports in conjunction with the Document Management System to allow management of your reports in a secure environment.

• Save and track reports within the database.
• Seamlessly integrate tables, graphs and text into final reports through an automated link to Microsoft® Word.
• Quickly and accurately create final reports using standard templates linked to study-specific information.
• Record document history, highlighting changes between versions of the document.
• Define columns, print order, assign macros, add free text, size the table and its position and even specify the decimal precision of the data.

• Further analyse or characterise existing samples.
• Create on-the-fly extraction pathways, displayed as a tree structure, adding extracts and samples as you go.
• Pool and concentrate samples, monitoring recovery and concentration at each stage.
• View and report all extraction data.
• Extraction trees can optionally be created as a stand-alone study.
• View all calculations.
• Can be used for any sample in any study, or as a stand-alone study.

• ADME study types include: mass balance, tissue distribution, blood : plasma ratio, pharmacokinetics.
• Easily configure complex protocols.
  – Multiple dose routes, species, dose rates.
  – Define sampling schedules.
• Design prepare and analyse dose solutions and dose vehicles.
• Create and perform dilutions on stock solutions.
• Interactively weigh subjects and administer dose.
• Capture sampling data directly from balances and LSCs.
• Full reporting at all stages with automatic generation of final summary tables.

• Multiple assay types available:
  Ultrafiltration.
  Equilibrium Dialysis.
  Blood Cell Partitioning.
• Set up studies with single or multiple species.
• Select multiple concentrations and number of replicates.
• Options to perform non-specific binding and time to equilibrium assays prior to the main study.
• Define spiking schedule and analyse the spiked samples.
• Create serial dilutions of stock solutions.
• Free/bound and other associated calculations automatically performed and reported.

• Perform rate of degradation studies including:
  OECD 307 – Aerobic soil / anaerobic soil.
  OECD 308 – Aqueous sediment.
  OECD 111 – Hydrolysis.
  OECD 106 – Adsorption /
  Desorption studies.
• Define soils with water holding capacity details.
• Determine soil moisture content.
• Calculation of target equivalent dry weight of dispensed soil.
• Dose rate calculations from field rates.
• Quickly apply known dose amount to all flasks.
• Adsorption / Desorption extraction trees.

• Specify application area (ha / m2 / cm2).
• Specify dose rate per area.
• Specify default areas.

• Direct links to Seescan WBA software.
• Use Debra’s core features to facilitate QWBA studies.
• Create batch worksheets to import WBA data from a variety of sources.
• Perform QWBA work as part of a larger ADME study or as a discrete project.
• Use Debra’s reporting tools for consistent and seamless reporting in a secure environment.

While originally designed for traditional ADME mass balance, tissue distribution (via cut & burn or WBA) and PK studies, Debra can be used for cold bioanalytical in vivo studies, protein binding assays, skin perfusion studies and a wide range of environmental fate protocols.

Provided you are using Debra 6, you can import data from any Debra database including Debra 5, enabling further analysis and reporting of studies run at your CRO as well as the ability to pool samples for metabolite profiling.

Typical instrument links include balances and liquid scintillation counters.  Any balance with an RS232/USB or Bluetooth connection can be linked to Debra, likewise all vintages of liquid scintillation counter can be interfaced to including Packard/Perkin Elmer Tricarbs, Hidex 300SL even your old standalone DOS based Beckman counters.

• Updates to the Debra program usually occur 1 to 2 times per year. Updates to the program are usually a result of comments and suggestions from our network of clients. In addition, our programmers are constantly improving the program to simplify functions even more.  When an update is installed, we include software release notes for your records, a summary for the changes made and how it may effect validation considerations.
• LabLogic operates a policy of not forcing clients to upgrade to the latest release. This enables sites that are happy with a current release to continue using there validated version until such time as they feel there is a real benefit to be gained or when it is more convenient.

Yes, full instructions of the upgrade path from Debra 5 to Debra 6 are available from our support team.

Charles River upgraded to Debra for its radiolabelled mammalian metabolism and environmental fate studies. Read what Geoff Burns, Director of Laboratory Sciences at Charles River Edinburgh had to say about the upgrade here.

Quotient Bioresearch, which has since been acquired by Pharmaron, upgraded to both Debra and Laura for its radiolabelled metabolism studies and radiochromatography work. Stephen Lewinton, Senior Vice President of UK Operations at Pharmaron, commented on the installation here.

In an issue of Scientific Computing World, Marko Miladinov, senior IT specialist at XenoBiotic Laboratories, writes about how Debra meets XenoBiotic's case requirements at the company's New Jersey research facility.  Read more here.

Contract research organisation XenoBiotic Laboratories purchased Debra LIMS solution to manage ADME data a few years prior. Read about the sale from Dennis Heller, Vice President for Pharmaceutical Development, here.

GLP/GCP-compliant contract research organisation QPS has installed Debra at its facility in Delaware. Ben Chien, PhD, QPS chairman comments on the upgrade here.

Xenometirics, a contract research organisation based in Kansas, chose Debra to manage their ADME data. Read what the president, Alfred Botchway, had to say about the purchase here.

The Massachusetts specialist chose ADME LIMS suitable for unlabelled compound data. Hear from Millennium's Project Manager, Csilla Csank, here.

Debra was chosen for six of Sanofi-Aventis' R&D facilities across Europe and North America. Read more about the deal here.

Debra was chosen for the company's R&D centre in Braine-l'Alleud, Belgium, which specialises in therapeutic solutions for disorders of the central nervous system. Read more here.