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Selectivity<br />
• It is critical to assess the performance of the cell<br />
line in target population matrix because cell lines<br />
may respond to serum factors other than the<br />
API. Such responses can confound data<br />
interpretation<br />
• Incorporation of Ab against serum factors has<br />
been successfully used to overcome this<br />
problem.<br />
• On-board drug in the serum can also impact<br />
assay performance<br />
• Samples should be obtained at trough drug<br />
levels to mitigate this problem. Samples<br />
obtained after a sufficient washout period<br />
(generally ~5 half lives) may also be needed
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