title: Preclinical bridging studies: understanding dried blood spot and plasma exposure profiles.
abstract: BACKGROUND
  Understanding the distribution of the analyte between the cellular and noncellular (plasma) components of the blood is important, especially in situations where dried blood spot (DBS) data need to be compared with plasma data, or vice versa.
  
  
  RESULTS
  Pearson's coefficient, Lin's coefficient and the Bland-Altman analysis are appropriate to evaluate the concordance between DBS and plasma data from bridging studies. Percent recovery plots generated using the ex vivo blood:plasma ratio and the regression equations demonstrate the best approach for predicting plasma concentrations from DBS.
  
  
  CONCLUSIONS
  Statistical analysis of bridging study data is needed to characterize the relationship or concordance between blood (DBS) and plasma. The outcomes also provide guidance on selecting the most appropriate approach to transform DBS data to plasma, or vice versa. However, the biological and statistical evidence must be weighed together when deciding if DBS is suitable for preclinical and/or clinical development.
authors: Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN, USA. enaksha@lilly.com
authors: Enaksha R
authors: ER
authors: Wickremsinhe
authors: Naijia H
authors: NH
authors: Huang
authors: Basira G
authors: BG
authors: Abdul
authors: Kirk
authors: K
authors: Knotts
authors: Kenneth J
authors: KJ
authors: Ruterbories
authors: Jason R
authors: JR
authors: Manro
mesh_terms: D000818:Animals; D001769:Blood; D004285:Dogs; D059788:Dried Blood Spot Testing / Q000379:methods*; D006801:Humans; D008297:Male; D010949:Plasma / Q000737:chemistry; D051381:Rats; D017207:Rats, Sprague-Dawley; D053719:Tandem Mass Spectrometry / Q000379:methods*