title: Implementing DBS methodology for the determination of Compound A in monkey blood: GLP method validation and investigation of the impact of blood spreading on performance.
abstract: BACKGROUND
  This article describes validation work for analysis of an Abbott investigational drug (Compound A) in monkey whole blood with dried blood spots (DBS). The impact of DBS spotting volume on analyte concentration was investigated.
  
  
  RESULTS
  The quantitation range was between 30.5 and 10,200 ng/ml. Accuracy and precision of quality controls, linearity of calibration curves, matrix effect, selectivity, dilution, recovery and multiple stabilities were evaluated in the validation, and all demonstrated acceptable results. Incurred sample reanalysis was performed with 57 out of 58 samples having a percentage difference (versus the mean value) less than 20%. A linear relationship between the spotting volume and the spot area was drawn. The influence of spotting volume on concentration was discussed.
  
  
  CONCLUSIONS
  All validation results met good laboratory practice acceptance requirements. Radial spreading of blood on DBS cards can be a factor in DBS concentrations at smaller spotting volumes.
authors.affiliation: Department of Drug Analysis, Abbott Laboratories, Abbott Park, IL 60064, USA. leimin.fan@abbott.com
authors.forename: Leimin
authors.initials: L
authors.lastname: Fan
authors.forename: Jacob
authors.initials: J
authors.lastname: Lee
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hall
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Tolentino
authors.forename: Huaiqin
authors.initials: H
authors.lastname: Wu
authors.forename: Tawakol
authors.initials: T
authors.lastname: El-Shourbagy
mesh_terms: D000818:Animals; D016477:Artifacts; D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards; D001800:Blood Specimen Collection / Q000379:methods* / Q000592:standards; D005615:Freezing; D000882:Haplorhini / Q000097:blood*; D057446:Hydrodynamics; D007753:Laboratories / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000097:blood*; D012015:Reference Standards; D013696:Temperature
chemical_list: D004364:Pharmaceutical Preparations