Incurred sample reanalysis (ISR) in drug discovery bioanalysis.

07:00 EST 9th November 2018 | BioPortfolio

Summary of "Incurred sample reanalysis (ISR) in drug discovery bioanalysis."

Bioanalysis plays a key role during drug discovery process to generate the pharmacokinetic data to facilitate unbiased evaluation of leads, optimized leads and drug candidates. Such pharmacokinetic data are used to enable key decisions in the drug discovery process. The aim of the work is to put forward a new strategy of performing the incurred sample reanalysis (ISR) for select small molecule Novel Chemical Entities (NCEs) at different stages of drug discovery prior to candidate selection. Three discovery programs representing hits, leads and optimized lead candidates were selected for the ISR analysis. From each discovery program, 2 NCEs were selected for the ISR analysis. The time points considered for ISR generally varied among the programs; however, samples coinciding with drug absorption, distribution and elimination were considered in the ISR assessment. With the exception of a single ISR value that gave a high deviation (about 63%), the observed ISR values supported the discovery bioanalytical assays. While the individual bioanalytical laboratory can draw an algorithm for selecting NCEs and fixing the acceptance criteria for the ISR data, it is proposed that the % difference between ISR vs. original concentration for the 67% of the repeat samples, is contained within ± 30% for discovery bioanalysis.


Journal Details

This article was published in the following journal.

Name: Biomedical chromatography : BMC
ISSN: 1099-0801
Pages: e4430


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