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Recommendation for Co-Medication Assay Interference Assessment

Interference testing has been an area of discussion with a number of regulatory guidance documents for Bioanalytical Method Validation, including the need to consider the impact of co-administered / co- formulated medicines on assay performance. The assessment of the impact of the medicines specified in a clinical protocol, or unplanned medication, is a regulatory requirement.
As a consequence of these guidelines, and in response to regulatory requests for stability data in the presence of co-administered drugs, assessments to show selectivity, accuracy, precision and matrix stability is unaffected by scheduled medications should be performed. However assessments using unscheduled medications are rarely performed.

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