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Method Precision/Accuracy/Range - Establish by spiking sample matrix with compound of interest at levels ranging from limit of quantitation to two times the specification limit.
The limit of quantitation for the analysis of the impactor sample was 0.
More specifically, the plasma levels of intact KP106 prodrug were below the limit of quantitation at all time points, whereas intact Vyvanse[R] levels were detectable and similar to previous reports.
At the end of week 1 (day 8 of VX-950 dosing), plasma HCV RNA was below the limit of quantitation (30 IU/mL; Roche Taqman(R) assay) in six of the 12 patients; and undetectable (less than 10 IU/mL; Roche Taqman(R) assay) in two of 12 patients.