title: High-throughput salting-out assisted liquid/liquid extraction and ultrafast LC for same-day delivery of first-in-human bioanalytical data.
abstract: BACKGROUND
  With the need of fast-paced drug development, rapid delivery of bioanalytical data becomes a trend. Here, we present a strategy to demonstrate same-day data delivery.
  
  
  RESULTS
  A novel salting-out assisted liquid/liquid extraction (SALLE) with acetonitrile and a MS-friendly salt was used to extract analyte from the first-in-human study plasma samples and the extract was successfully injected into ultrafast chromatography. The strategic combination of SALLE and ultrafast chromatography minimizes the turnaround time and allows the same-day delivery of bioanalytical data. The time saving from both extraction and injection was translated to a fast delivery of bioanalytical data.
  
  
  CONCLUSIONS
  The first-in-human pharmacokinetic data of an investigational new drug candidate was delivered in approximately 4.5 work h after receiving the samples of each dose group using high-throughput SALLE and ultrafast LC. Incurred sample reassay results proved uncompromised data quality with the high-speed bioanalysis.
authors.affiliation: Department of Drug Analysis, Abbott Laboratories, Abbott Park, IL 60064, USA. jun.zhang@abbott.com
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Francis
authors.initials: F
authors.lastname: Myasein
authors.forename: Ramona
authors.initials: R
authors.lastname: Rodila
authors.forename: Huaiqin
authors.initials: H
authors.lastname: Wu
authors.forename: Tawakol A
authors.initials: TA
authors.lastname: El-Shourbagy
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D002138:Calibration; D005591:Chemical Fractionation / Q000379:methods*; D002853:Chromatography, Liquid / Q000379:methods*; D015507:Drugs, Investigational / Q000737:chemistry / Q000302:isolation & purification*; D057166:High-Throughput Screening Assays; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods; D011786:Quality Control; D012492:Salts / Q000737:chemistry
chemical_list: D000097:Acetonitriles; D015507:Drugs, Investigational; D012492:Salts; C032159:acetonitrile