title: A simple, effective approach for rapid development of high-throughput and reliable LC-MS/MS bioanalytical assays.
abstract: BACKGROUND
  Rapidly developing LC-MS/MS assays with high-throughput and quality are challenging yet desired. Methodology & results: A simple method development approach was reported and demonstrated with the quantitative bioanalysis of BMS-984478, a hepatitis C virus nonstructural protein 5A inhibitor. An accurate, precise and robust LC-MS/MS method for the quantitation of BMS-984478 in rat and monkey plasma was developed and validated. Incurred sample reanalysis evaluation passed with 100% of samples meeting the acceptance criteria. The validated assay was successfully applied in toxicology studies without any failed runs.
  
  
  CONCLUSIONS
  The approach was successfully applied to the bioanalysis of BMS-984478 in toxicology and clinical studies. This approach was shown to be effective and reliable in speeding the development of high-throughput and reliable LC-MS/MS assays.
authors: Bioanalytical Sciences, Research & Development, Bristol-Myers Squibb Co., Princeton, NJ 08543, USA.
authors: Long
authors: L
authors: Yuan
authors: Bioanalytical Sciences, Research & Development, Bristol-Myers Squibb Co., Princeton, NJ 08543, USA.
authors: Anne-Françoise
authors: AF
authors: Aubry
authors: Bioanalytical Sciences, Research & Development, Bristol-Myers Squibb Co., Princeton, NJ 08543, USA.
authors: Qin C
authors: QC
authors: Ji
mesh_terms: D000818:Animals; D000998:Antiviral Agents / Q000097:blood* / Q000633:toxicity; D002851:Chromatography, High Pressure Liquid / Q000191:economics / Q000379:methods; D000882:Haplorhini; D016174:Hepacivirus / Q000187:drug effects; D006526:Hepatitis C / Q000188:drug therapy; D006801:Humans; D057230:Limit of Detection; D051381:Rats; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000191:economics / Q000379:methods*; D017361:Viral Nonstructural Proteins / Q000037:antagonists & inhibitors*; D012324:RNA-Dependent RNA Polymerase
chemical_list: D000998:Antiviral Agents; D017361:Viral Nonstructural Proteins; C087036:NS-5 protein, hepatitis C virus; D012324:RNA-Dependent RNA Polymerase
keywords: UHPLC–MS/MS; incurred sample; matrix effect; metabolite interference; method development; regulated bioanalysis