The worlds leading metabolism Laboratory Information Management system 

Debra is a purpose built LIMS designed specifically to manage the entire life cycle of a range of drug and environmental metabolism studies within a FDA/GLP regulated environment. 

Continuous development over 15 years has resulted in a system that is the industry standard in its field and is used by many of the world's leading Pharmaceutical, Agrochemical and Contract Research Organizations.

Improved Quality and Compliance

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 product by analytical equipment. No transcription is necessary.

Seamless communication is provided to and from the instrumentation software.  A wide variety of models and version of LSC, balances and WBA links are handled with instrument specific interfaces.

Debra is designed to fully support GLP and associated regulatory requirements.  This includes functionality to meet with the FDA 21 CFR Part 11 ruling for electronic signatures and electronic records.  The system allows for System Manager configurable control of signature points on key events of the study process.

Improved Efficiency

Save time and reduce costs.  Through managing data electronically Debra significantly improves workflow efficiency throughout various phases of a metabolism study.

No more cut and paste of data between spreadsheets.

Removal of tedious quality control of data.

Scalable

From single user labs through multi-site global organizations, 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.

Workflow Modules

Protocol

Modern protocols are increasingly complex. Debra has been designed from the ground up to handle this complexity. The full range of ADME studies are easily handled including Mass Balance, Tissue Distribution, PK and any combination of the above. Unlike LIMS that are essentially QC tracking systems with a protocol module added on, Debra is designed to facilitate the achievement of study objectives.

When a study is created, the default configuration values associated with its related project will be applied to the study to achieve consistency while maintaining maximum flexibility. This will also allow for the creation of cross-study analysis reports.

Once a study has been accepted, Debra will provide an audit trail detailing changes made to the study. Deviations and amendments are tracked for each study.

Treatment

The Treatment Module allows for the design, creation, preparation and analysis of the different dose preparations for your project, as well as the preparation of Dose Vehicles. There is no limit to the number or types of dose preparation the user can add per project thus allowing for multi-dose and crossover study designs to be accommodated.

Twelve predefined methods are available for dose preparation to cater for most working practices, e.g. whether you add the solid compound or prepare solutions of the compounds in advance. The module is fully interactive, prompting the user for information. The module incorporates full GLP audit features and is fully FDA 21 CFR Part 11 compliant, catering for modifications along with direct interface to laboratory equipment (e.g. balances, pipettes, LSC) for seamless integration of raw data without transcription error.

The analysis phase allows you to design a plan for taking aliquots of your dose solution in order to check that the activity and concentration of the prepared dose solution matches the expected target values. The user can choose the number of aliquots, whether a dilution step is needed and whether the replicates need to be weighed or entered as a volume. The final results screen shows the calculated results, statistics across flasks and aliquots and a comparison deviation from the nominal values entered in the design screens.

Dosing

The interactive Dosing Module gives the facility for the interactive weighing and dosing of the subjects. Dosing and Treatment Modules are linked to provide data on the specific activity of the treatment being dosed. The link allows the system to check dosing volumes/weights and calculate the amount of activity administered.

There are several methods from which to choose covering the variety of options currently used in the metabolism laboratory. Multi-dose studies using multiple dose preparations are catered for. The user can record the actual time of dose and any associated comments/observations. The recorded time of dose can be used within the system to calculate real-time sampling for PK studies.

As with all Debra's modules the system comes complete with full GLP audit facilities, is fully FDA 21 CFR Part 11 compliant and links to laboratory instrumentation for the direct capture of all raw data.

Samples

Core to Debra is the ability to collect many types of data associated with each sample.

Data transferred directly from the balance workstation eliminates transcription errors and speeds up the process of weighing doses, tissues and aliquots.  Virtually any balance with an RS232 or USB interface can be interfaced directly into the system.  Worksheets generated by the system are flexible enough to allow the operator a choice of samples, time-points, working methods, sorting order etc.  Debra records whether the data was entered via the keyboard or on-line as well as recording any comments the analyst may have on the sample. All the above items are visually marked using icons beside the data collected.

Direct collection of liquid scintillation counter data has the same advantages as the balance data collection though implementation is somewhat different due to the variety of counter types available - each having its own unique data output format.  Debra is equipped with device drivers that decode the output from most popular counters.  For older model counters Debra has a software companion called Jane that will ‘modernise’ the counter data collection and output.  Various options for background corrections, efficiency standards and oxidised samples are definable both by user defined pattern templates or drag and drop options.

Splitting and Pooling

Samples may be split and pooled within Debra to create additional samples for further analysis. Samples may be pooled by dose group, gender or by timepoint. Debra can calculate a percentage amount to be split, and calculate which samples need to be pooled based on percentage recovery of the dose. The user may choose to use theoretical weights and counts for the pooled samples or you can capture all the data online using Debra's weight and LSC batch functions.

Calculations and Review

Simply put there is no faster method that we know of to go from raw data to final results than the Debra system.  For a typical study with approximately 66,000 data points, final results and summary tables can be obtained minutes after the last sample is weighed and counted.  Received a change in the specific activity?...no problem.  One quick edit and back to final table in minutes!!

Calculation options have now been integrated with the reports options.  The type of reports you design will dictate which calculations need to be performed.  Design the report or select one of the predefined reports and the latest results appear in seconds.

Debra contains numerous options and methods for calculating final results.  The most basic of these options include, but are not limited to, the following:

  1. Number of decimal places and significant figures to be used
  2. Include mean, total, SD, CV, STE, F-value
  3. Include or exclude subjects, tissues, time-points
  4. Rules for limit of detection methodology
  5. Lookup tables for result adjustment to total weight, percentage of whole or cumulative results
  6. Tissue grouping
  7. Normalise data to nominal dose level

Of course, to eliminate any confusion about how results were produced, each summary report is stamped with a calculation report code.  This report code can be used to generate a report that details all options chosen, right down to the paper size and margins for that particular summary report.

Reports

Debra has many facilities for reporting the various results and parameters defined within a study.  In addition, there is the facility for the user to ‘build’ custom outputs and reports using Debra’s report editor and save them as templates for future use.  All reports may be directed to a printer or output to a number of predefined formats for easy import into other software.  Although too numerous to mention them all, the Debra formats include the following main reports :

  1. Raw data report
  2. Protocol definition
  3. Weight/LSC data acceptance report
  4. Audit trail report
  5. Treatment report
  6. Dosing report
  7. Summary tables (means, totals, SD, CV)

Additional Modules

Labelling

Tired of printing out labels for your study on a separate package? The labelling module of Debra allows the user to generate project specific labels in any number of user-defined formats based on the project data entered into the system.

Both the label type/size and the content are defined by the user, making it a flexible and powerful tool. Pre-defined label formats can be set to cover the corporate standard. Adding barcodes to the labels will allow the user to take advantage of bar-coding options for data collection, that not only speeds up the processes within the laboratory, but also reduces the risk of user error.

Regulatory Compliance

Debra has a comprehensive and flexible security structure, which is used to control access to menu items and form-level functions. Given that Debra is used in a regulatory environment, it is important that Debra is able to guard against unauthorised access to studies. Therefore, security is assigned on a user/study basis. System and study-level security roles can be assigned to users to ensure that only those individuals who have the appropriate rights assigned to them can perform their necessary functions.

Instrument Management

Interfacing

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. There is no transcription necessary. Seamless communication is provided to and from the instrument software. A wide variety of models and versions of Balances, LSC’s and WBA are handled with instrument specific interfaces.

Document Management System

The reporting package provides exceptional convenience and flexibility. Define columns, print order, assign macros, add free text, size the table and its position and even specify the decimal precision of the data. All reports generated in Debra may be saved to the database using Debra's Document Management System. This is a unique system that seamlessly provides for the integration of tables, graphs and text into final reports through an automated link to Microsoft® Word. Debra records the document history, highlighting changes between versions of the document. As such, the assembly of critical pieces of information, through standard templates linked to study-specific reports, quickly and accurately facilitates the creation of final reports.

Study Modules

WBA

The WBA module can enhance the performance of the metabolism laboratory by utilizing common features used routinely in ADME studies within the Debra package. The use of the project driven treatment, dosing and reporting functions allows QWBA to exist as part of a larger ADME study, or as a discrete project. Within Debra, QWBA reports can also be saved to the Document Management System for seamless reporting in a secure environment.

Laura (Radiochromatography)

A link to our industry-standard radio-chromatography software is now available. This permits two-way exchange of data between Laura and Debra. For example, projects and sample data can be created in Debra and subsequently imported into Laura. In addition, chromatograms and region table data from Laura are available for further analysis and reporting in Debra. Security for both systems can be linked, so that users can have one username and password for access to Laura and Debra.

Protein Binding

Protein binding assays, including blood cell partitioning, equilibrium dialysis, ultracentrifugtaion and ultrafiltration, can be performed. Debra accommodates the full process, from assay design to stock solution preparation, sample spiking, calculation of results and reporting.

What types of study can I perform in Debra ?

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.

Can I exchange data between my contract laboratory and my laboratory ?

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.

What instrumentation can I link to Debra ?

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.

How often are there updates to Debra ?

  • 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.

Can I upgrade my data from Debra 5 to Debra 6 ?

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

Documents

Application Notes

Plasma Pharmacokinetics and Tissue Distribution of a N-Pyrrolo- [1,2-c]Imidazolylphenyl Sulfonamide in Rats
Mehran F. Moghaddam, Matthew S. Bogdanffy, Alethia Brown, Kim Ford, and Lamaat Shalaby. Nutrition and Health (M.F.M.). Drug Metabolism and Disposition, Vol. 30, Issue 1, 47-54, January 2002

Pharmacokinetics, Metabolism, and Excretion of Linezolid following an Oral Dose of [14C]Linezolid to Healthy Human Subjects
J. G. Slatter, D. J. Stalker, K. L. Feenstra, I. R. Welshman, J. B. Bruss, J. P. Sams, M. G. Johnson, P. E. Sanders, M. J. Hauer, P. E. Fagerness, R. P. Stryd, G. W. Peng, and E. M. Shobe. Drug Metabolism and Disposition, Vol. 29, Issue 8, 1136-1145, August 2001

Pharmacokinetics, Metabolism, and Excretion of Irinotecan (CPT-11) Following I.V. Infusion of [14C]CPT-11 in Cancer Patients
John Greg Slatter, Larry J. Schaaf, James P. Sams, Kenneth L. Feenstra, Mark G. Johnson, Paul A. Bombardt, Karen Sue Cathcart, Michael T. Verburg, Laura K. Pearson, Linda D. Compton, Langdon L. Miller, David S. Baker, Caroline V. Pesheck, and Raymond S. Lord, III. Drug Metabolism and Disposition, Vol. 28, Issue 4, 423-433, April 2000