DBS is an analytical technique that is gaining acceptance as a superior alternative to traditional plasma collection in both preclinical and clinical drug development studies.  It provides both accurate and reliable results with the potential to dramatically reduce overall study costs.  Many drug development companies find there are advantages to using this technique, especially for preclinical toxicology studies, clinical pediatric studies, and studies conducted in remote geographic areas where centrifuges and freezers are not readily available.

Advantages:

  • Lower sample volume requirements (15-40 mcL)
  • Fewer animals, less drug substance needed for toxicology studies leading to improved PK/TK profile
  • Better TK data correlation due to less inter-subject variability
  • Less physical stress for study subjects
  • Reduced shipping and storage costs – ambient, non-hazardous
  • Faster sample processing/extraction times
  • Potential for improved analyte stability
  • Safer to handle – many viruses are inactivated when blood is dried
  • Can also be applied for both cerebral spinal fluid (CSF) and urine sample collection

Disadvantages:

  • Assay sensitivity (1-5 ng/mL range)
  • Limited automation options
  • Regulatory acceptance (Est. 2013)

DBS at KCAS:

KCAS has the expertise to support your preclinical and clinical DBS studies by providing:

  • Method Development and/or Method Optimization to improve assay performance
  • GLP Method Validation or Non-GLP Method Verification, as necessary
  • Preclinical and Clinical sample analysis – non-GLP or GLP and GCP
  • Sample Collection Kits and Shipping Supplies
  • Long-term Sample Storage

Contact us to learn more