Developing Bioanalytical Methods for BE Studies: Strategy, Validation, and Regulatory Alignment
Developing Bioanalytical Methods for BE Studies: Strategy, Validation, and Regulatory Alignment How to Develop Bioanalytical Methods for Bioequivalence Studies Introduction: Why Method Development Is Critical in BA/BE Bioequivalence (BE) studies rely on precise and accurate measurement of drug concentrations in biological matrices, typically plasma or serum. This requires robust, reproducible, and validated bioanalytical methods, most…