HT-ADME in a contract research organization laboratory: can you ensure bioanalytical quality in a highly automated environment?

“As with any bioanalytical assay that relies on LC–MS/MS for end point quantification, key parameters need to be established to ensure robust, accurate data are collected.” It is well documented that between 1991 and 2000, the attrition of new chemical entities in the clinic due to poor PK fell from ˜40 to ˜10% [1]. This reduction in PK failure was due to the growth of drug metabolism and PK assessments within drug discovery, in particular in vitro adsorption, distribution, metabolism and excretion (ADME) assays.   These ADME assays provide a quick and efficient manner in which a compound’s potential PK properties...

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