Dried Blood Spot (DBS) technique will bring ethical, scientific and cost benefits

07-08-2010

Evreux, France, July 8, 2010 - CIT, an independent preclinical contract research organization (CRO), announces today that it is now offering the Dried Blood Spot (DBS) technique to its clients worldwide. The new service is in line with CIT's policy of continuous enhancements to the range it offers its customers.
 
The DBS technique is a sample processing and storage method in which small samples of blood are taken, dried on pre-treated paper cards and stored for subsequent analysis. This technique avoids the preparation of plasma, and permits the use of very small samples (typically between 10 and 50 microliters of blood) for pharmacokinetic and/or toxicokinetic analyses. It also facilitates sample storage, archiving and shipment. At the time of analysis, the drug is recovered from the paper card by solvent extraction and analyzed by traditional chromatographic (or other) techniques.
 
Many small molecule therapeutics can benefit from the DBS approach. Preliminary verification in the laboratory will determine its applicability. Pediatric medicine was among the first to use the technique and it is now arousing great interest in other fields.

Adoption of the DBS technique will bring ethical, scientific and cost benefits to CIT clients. For example, the small sample volume means that in many cases rodent studies will not need to use extra groups of animals just for pharmacokinetic monitoring, thus bringing a corresponding reduction in animal use. In the best cases, it will be possible to obtain a complete pharmacokinetic profile from a single rodent animal. The technique can be used across the range of discovery and regulatory toxicology, pharmacology and pharmacokinetics studies. It will also facilitate the performance of studies with animals having a limited blood volume (such as juvenile animals or transgenic mice).
 
As an example of the use of this approach, CIT has validated the bioanalytical method (using DBS) for determination of sulpiride in dog blood. This guideline-compliant study confirmed that acceptable values are obtained for validation parameters such as precision and accuracy when the DBS technique is used. Over the next few months CIT will be presenting work on the DBS technique at several meetings such as American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and the European Bioanalysis Forum (EBF).
 
"In the current competitive environment, CIT has to be quick to bring the benefits of new technical approaches to our clients," said Dr Thibault Ameller, Head of the Drug, Metabolism and Pharmacokinetics Department at CIT. "This approach can reduce animal use by up to 60 per cent and study costs by 11 to 25 per cent in a typical rodent project for an IND-enabling dossier."

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