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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.
This article was published in the following journal.
Name: Biomedical chromatography : BMC
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The process of finding chemicals for potential therapeutic use.
The analysis of a chemical substance by inserting a sample into a carrier stream of reagent using a sample injection valve that propels the sample downstream where mixing occurs in a coiled tube, then passes into a flow-through detector and a recorder or other data handling device.
A type of scanning probe microscopy in which a very sharp conducting needle is swept just a few angstroms above the surface of a sample. The tiny tunneling current that flows between the sample and the needle tip is measured, and from this are produced three-dimensional topographs. Due to the poor electron conductivity of most biological samples, thin metal coatings are deposited on the sample.
A solventless sample preparation method, invented in 1989, that uses a fused silica fiber which is coated with a stationary phase. It is used for sample cleanup before using other analytical methods.
An immunoenzyme test for the presence of drugs and other substances in urine and blood. The test uses enzyme linked antibodies that react only with the particular drug for which the sample is being tested.
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