title: Validation of LC-MS/MS bioanalytical methods for protein therapeutics.
authors.affiliation: Roche Pharma Research & Early Development, Roche Innovation Center New York, Roche TCRC Inc., 430 East 29th St., New York, NY 10016, USA.
authors.forename: Faye
authors.initials: F
authors.lastname: Vazvaei
authors.forename: Jeffrey X
authors.initials: JX
authors.lastname: Duggan
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000592:standards; D004798:Enzymes / Q000378:metabolism; D006801:Humans; D008024:Ligands; D011506:Proteins / Q000032:analysis* / Q000378:metabolism / Q000592:standards; D012015:Reference Standards; D053719:Tandem Mass Spectrometry / Q000592:standards
chemical_list: D004798:Enzymes; D008024:Ligands; D011506:Proteins
keywords: PrD-LC–MS; enzymatic digestion; hybrid methods; protein digestion LC–MS/MS; quantitative protein LC–MS/MS; regulated biotherapeutic bioanalysis; validation