title: Dried blood spot sampling: coupling bioanalytical feasibility, blood-plasma partitioning and transferability to in vivo preclinical studies.
abstract: BACKGROUND
  The adoption of dried blood spot (DBS) sampling and analysis to support drug discovery and development requires the understanding of its bioanalytical feasibility as well as the distribution of the analyte in blood.
  
  
  RESULTS
  Demonstrated the feasibility of adopting DBS for four test analytes representing diverse physico-chemical as well as pharmacokinetic parameters. The key findings include the use of a single extraction procedure across all four analytes, assay range of 1 to 5000 ng/ml, stability in whole blood as well as on-card, and the non-impact of blood volume. In vivo data were used to calculate the blood-to-plasma ratio (using both AUC and average of individual time points), which was then used to predict plasma concentration from DBS data. The predicted data showed an excellent correlation with actual plasma data.
  
  
  CONCLUSIONS
  Transition from plasma to DBS can be supported for preclinical studies by conducting a few well-defined bioanalytical experiments followed by an in vivo bridging study. Blood:plasma ratio derived from the bridging study can be used to predict plasma concentrations from DBS data.
authors.affiliation: Lilly Research Laboratories, Eli Lilly & Company, IN, USA. enaksha@lilly.com
authors.forename: Enaksha R
authors.initials: ER
authors.lastname: Wickremsinhe
authors.forename: Basira G
authors.initials: BG
authors.lastname: Abdul
authors.forename: Naijia H
authors.initials: NH
authors.lastname: Huang
authors.forename: John W
authors.initials: JW
authors.lastname: Richard
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Hanes
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Ruterbories
authors.forename: Everett J
authors.initials: EJ
authors.lastname: Perkins
authors.forename: Ajai K
authors.initials: AK
authors.lastname: Chaudhary
mesh_terms: D001798:Blood Proteins / Q000737:chemistry; D059788:Dried Blood Spot Testing / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D004364:Pharmaceutical Preparations / Q000097:blood; D010949:Plasma / Q000737:chemistry*
chemical_list: D001798:Blood Proteins; D004364:Pharmaceutical Preparations