title: Development and validation of an enzyme-linked immunosorbent assay to measure adalimumab concentration.
abstract: BACKGROUND
  Adalimumab is a therapeutic antibody used for treating inflammatory diseases. To understand interindividual PK variability, there is a need to develop and validate an assay to measure serum adalimumab concentrations.
  
  
  METHODS
  An ELISA was developed on microtiter plates coated with TNF-α. Seven nonzero adalimumab standards ranging from 0.05 to 50 mg/l and three quality controls (0.2, 2.5 and 7 mg/l) were tested for their intra and interday precision on six occasions.
  
  
  RESULTS
  The LOD, LLOQ and ULOQ of the assay were 0.022, 0.073 and 9 mg/l, respectively.
  
  
  CONCLUSIONS
  This method is accurate, reproducible and may be useful for PK studies and for therapeutic drug monitoring of adalimumab.
authors.affiliation: 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.|2CHRU de Tours, Laboratory of Pharmacology-Toxicology, Tours, France.
authors.forename: Céline
authors.initials: C
authors.lastname: Desvignes
authors.affiliation: 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.
authors.forename: Soujanya R
authors.initials: SR
authors.lastname: Edupuganti
authors.affiliation: 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.|2CHRU de Tours, Laboratory of Pharmacology-Toxicology, Tours, France.
authors.forename: François
authors.initials: F
authors.lastname: Darrouzain
authors.affiliation: 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.|2CHRU de Tours, Laboratory of Pharmacology-Toxicology, Tours, France.
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Duveau
authors.affiliation: 4Clinical Immunology, GlaxoSmithKline, Upper Merion, 709 Swedeland Road, Kings of Prussia, PA 19406, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Loercher
authors.affiliation: 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.|2CHRU de Tours, Laboratory of Pharmacology-Toxicology, Tours, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Paintaud
authors.affiliation: 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.|3CHRU de Tours, Department of Rheumatology, Tours, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Mulleman
mesh_terms: D000068879:Adalimumab / Q000097:blood*; D000893:Anti-Inflammatory Agents / Q000097:blood*; D016903:Drug Monitoring / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D006801:Humans; D057230:Limit of Detection; D015203:Reproducibility of Results
chemical_list: D000893:Anti-Inflammatory Agents; D000068879:Adalimumab