Non-regulated LC–MS/MS bioanalysis in support of early drug development: a Novartis perspective

Fu Y, Li W & Picard F | Bioanalysis, 15(3), 109-125, (2023) Keywords: • bioanalysis • instability • internal standard cocktail • LC–MS/MS • mobile phase additive • non-liquid matrix • non-regulated • non-specific binding • pitfalls • protein precipitation Scientifically qualified LC–MS/MS methods are essential for the determination of small molecule drug candidates and/or their metabolite(s) in support of various non-regulated safety assessment and in vivo absorption, distribution, metabolism and excretion studies in preclinical development. This article outlines an effective method development workflow to fit for this purpose. The workflow features a ‘universal’ protein precipitation solvent for efficient sample...