title: An investigation of the comparability of commercially sourced plasma and pharmaceutical study plasma, using total protein concentration.
abstract: BACKGROUND
  Control blood plasma is regularly used in bioanalysis, biomarkers and proteomics, and is often obtained from commercial sources. It has always been assumed that this plasma will be comparable to plasma drawn during a drug development study.
  
  
  RESULTS
  When compared using total protein concentrations, plasma from only one species (dog) demonstrated statistical comparability, plasma from all other species tested (human, rabbit, mouse and rat) shows a statistically significant difference.
  
  
  CONCLUSIONS
  If endogenous components of blood plasma are being measured, or if an assay technique does not significantly limit matrix effects, any assay controls should be prepared using control plasma from the drug development site, or using commercial plasma that has been screened against drug development site plasma.
authors.affiliation: GlaxoSmithKline, David Jack Centre, Research & Development, Park Road, Ware, Hertfordshire SG12 0DP, UK.
authors.forename: Clive
authors.initials: C
authors.lastname: Felgate
authors.affiliation: GlaxoSmithKline, David Jack Centre, Research & Development, Park Road, Ware, Hertfordshire SG12 0DP, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Spooner
authors.affiliation: GlaxoSmithKline, David Jack Centre, Research & Development, Park Road, Ware, Hertfordshire SG12 0DP, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Calloway
mesh_terms: D000818:Animals; D001774:Blood Chemical Analysis / Q000592:standards*; D001798:Blood Proteins / Q000032:analysis*; D006801:Humans; D011786:Quality Control; D012015:Reference Standards
chemical_list: D001798:Blood Proteins
keywords: control blood plasma; endogenous; method validation; preanalytics