Building on our experience of Debra for managing in vivo metabolism studies, new functionality has been added to the latest Debra 6 release specifically for users working in environmental fate.

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 and balances 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.

Study Types

Debra can be used for a range of soil, plant and large animal studies, including but not limited to:

  • OECD 307 - aerobic and anaerobic soil degradation and metabolism
  • OECD 308 - and metabolism studies in water/sediment systems under aerobic and anaerobic incubation conditions
  • OECD 106 - soil adsorption
  • OECD 111- hydrolysis studies

Soil Management

  • Configuration of soil test systems, including the Water Holding Capacity at various pressures.
  • Analysis of the Moisture Content of Test Systems prior to their use on study.
  • Dispensing of Soil Test Systems based on the Dry Weight Equivalent of the Soil.
  • Measurement and adjustment of the Moisture Content of the Test System throughout the course of the study, including the ability to check for items not measured over the past 24 hours.

Trace – sample extraction

Built into Debra is the ability to track the pathway for residue extractions enabling you to visualise the method used and keep track of the recovery and concentration of your sample at each stage of the process.  All calculations are shown for easy QA and verification of calculated results.

Link to Laura

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.

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