Is the Dilution Method for Measuring IC50 Shift Values a More Sensitive Approach for Evaluating Time-Dependent Inhibition?

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September 30,2024

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In 2022, with the promulgation of ICH M12, the evaluation methods for TDI in drug interactions became elusive. The original regional guidelines such as the FDA did not specify the IC₅₀ shift method, but the M12 guidelines pointed out that the dilution method should be used for the IC₅₀ shift. This has sparked extensive discussions in the industry. Based on the internally validated IC₅₀ shift system, we conducted a comparative study of the dilution and non-dilution methods.

Is the Dilution Method for Measuring IC50 Shift Values a More Sensitive Approach for Evaluating Time-Dependent Inhibition?

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