Co-medication and interference testing in bioanalysis: a European Bioanalysis Forum recommendation

Area of Science:

• Bioanalytical chemistry
• Pharmacokinetics
• Analytical method validation

Background:

• Modern bioanalytical techniques like LC-MS/MS and LBA offer high specificity.
• The necessity of co-medication interference testing in method validation is debated.
• The European Bioanalysis Forum (EBF) has extensive experience in this area.

Purpose of the Study:

• To evaluate the impact of co-medication on bioanalytical method performance.
• To provide science-based recommendations for evaluating co-medication interference.
• To guide the documentation of interference effects on pharmacokinetic (PK) parameters.

Main Methods:

• Analysis of hundreds of bioanalytical methods.
• Evaluation of co-medication impact on method performance.
• Leveraging extensive industry experience from EBF member companies.

Main Results:

• Data from hundreds of methods were analyzed to understand co-medication effects.
• The study assessed the real-world impact of co-administered drugs on assay performance.
• Insights were gained into the necessity and extent of interference testing.

Conclusions:

• Co-medication interference testing requires a science-based approach.
• Recommendations are provided for evaluating and documenting interference.
• The findings aim to standardize practices in bioanalytical method validation for clinical studies.