Download Poster

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.

Please complete the form below to download Recommendation for Co-Medication Assay Interference Assessment.

Name
Email
Company