Preface to The 2013 Special Focus Issue of Bioanalysis on High-Resolution MS

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Interest in using high-resolution MS (HRMS) continues to grow. In addition to DMPK applications [1,2], it is now being used for clinical and doping applications [3,4] as well as toxicological and forensic applications [5–7]. This special edition of Bioanalysis focusing on HRMS is a follow-up to the 2012 special focus issue of Bioanalysis on HRMS. The 2012 publication focused primarily on discovery bioanalysis plus metabolite identification applications of HRMS. The 2013 publication expands the focus to include regulated bioanalysis, peptide quantitation and protein therapeutics, as well as editorials and opinions on various HRMS topics, including using HRMS for forensic and clinical toxicology. In addition, there are articles on the utility of various software tools that are being developed to facilitate the ability to use HRMS for various applications. This 2013 special focus issue of Bioanalysis focusing on HRMS is a collection of articles that update and expand the scope of how HRMS is being used by scientists engaged in various aspects of new drug discovery and drug development. There are three review articles: one on metabolite identification with HRMS [8]; one on using microflow LC–HRMS for bioanalysis [9]; and one on structural characterization of protein therapeutics [10]. There is one article describing software automation tools for using HRMS in metabolic stability screening [11]. There are two perspective articles: one focused on HRMS in discovery bioanalysis [12] and one focused on regulated bioanalysis [13]. There are five editorial and/or opinion pieces: beyond the paradigm shift [14]; metabotype analysis by HRMS [15]; benefits and pitfalls of HRMS [16]; peptide quantification by HRMS [17]; and HRMS for forensic and clinical toxicology [18]. Finally, there are four research articles on HRMS: a metabolite profiling and reactive metabolite case study [19]; large molecule quantification study [20]; metabolomics and data-mining tools [21]; and a report on using HRMS for a regulated bioanalysis assay of six bile acids [22]. Together, these articles demonstrate the rapid expansion of interest in using HRMS for multiple types of assays of interest to not only DMPK scientists, but also scientists involved in various areas of pharmaceutical science from discovery to clinical applications for both small and large molecules.