LC-MS in drug discovery and development

The most important application area of LC-MS is in dmg development within the pharmaceutical industry. LC-MS is involved in almost every step. Drag development involves a series of specialized research efforts, which should in the end lead to the introduction of a novel drag onto the market. Traditionally, the drag development process consists of four steps drag discovery, preclinical development, chrrical developmerrt, and manirfacturing [1]. 

In the preclinical development stage, data are collected in order to enable the filing of an investigational new drag (in the US) or a clinical trial application (in Europe). These data are comprised of details on the composition of the drag and the 

The manufacturing phase often starts during the Phase-Ill clinical studies. In this phase, issues related to large-scale production, formulation, and packaging are addressed. Standardized analytical procedures for routine monitoring and release by quality control should be established. Long-term stability studies are now performed. 

An important aspect of the drug development process is that in early developmental phases the analysis is directed at a relatively small number of samples of a wide variety of compounds, while at a later stage the number of analytes is significantly reduced but the number of samples to be analysed per compound increases exponentially. Routinely applicable, robust, and sensitive analytical methods are required in the various phases of the process. 

It is virtually impossible to review the current applications of LC-MS in the pharmaceutical research area, mainly because for confidentiality reasons most of the work is not published in the public domain. The discussion is not meant as a complete overview of the pharmaceutical applications of LC-MS, but only shows a number of typical examples and highlights developments with an emphasis on technology rather than results. 

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