title: Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC-MS/MS.
abstract: BACKGROUND
  Enzalutamide is an androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway. Oral enzalutamide was recently approved by the US FDA and health authorities in other regions for the treatment of patients with metastatic castration-resistant prostate cancer who previously received docetaxel. The objective of this study was to validate a method for quantification of enzalutamide and its two major metabolites in human plasma.
  
  
  RESULTS
  The analytes were extracted from plasma by an LLE procedure, separated by reversed phase HPLC and detected by MS/MS in positive mode ESI. The quantitation range was 0.0200-50.0 µg/ml.
  
  
  CONCLUSIONS
  The method proved to be rapid and simple, and met FDA validation criteria.
authors: inVentiv Health Clinical Lab, Inc, 301D College Road East, Princeton, NJ 08540, USA.
authors: Daniel
authors: D
authors: Bennett
authors: Jacqueline A
authors: JA
authors: Gibbons
authors: Roelof
authors: R
authors: Mol
authors: Yoshiaki
authors: Y
authors: Ohtsu
authors: Clark
authors: C
authors: Williard
mesh_terms: D001549:Benzamides; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D008297:Male; D013058:Mass Spectrometry / Q000379:methods*; D009570:Nitriles; D010669:Phenylthiohydantoin / Q000031:analogs & derivatives* / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D015398:Signal Transduction
chemical_list: D001549:Benzamides; D009570:Nitriles; D010669:Phenylthiohydantoin; C540278:enzalutamide