Bioanalysis Zone

The practicalities of a ‘fit-for-purpose’ validation


The role of bioanalysis in drug discovery is well documented for the support of in vitro ADME activities and sample analysis for PK [1]. It is also a valuable tool for other drug discovery functions where, for example, the presence or not of drug may add to the value of other measured end points. Hill visited this subject with his editorial in this journal in 2011 [2]. In this article, we would like to discuss the practicalities of a ‘fit-for-purpose assay’ for compounds that may be only seen once during drug discovery. With more drug discovery being carried out by small, dedicated companies which have no bioanalytical experience, then it is important that the bioanalysts have input into the projects and can show that their methods are reliable for the purpose that they are used for.

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