Bioequivalence and Bioavailability Forum

Dear All,

According to ICH M10, recovery testing is not required during validation but should instead be assessed during method development. In contrast, the FDA Bioanalytical Method Validation Guideline (2018) requires recovery testing as part of the validation process.

Does the adoption of ICH M10 makes FDA 2018 guideline obsoleted for bioanalytical method validation? Unlike the EMA, which has clearly stated that ICH M10 replaces its existing guideline, the FDA does not appear to have made a similar announcement

is it ok not to perform recovery testing, at least for EU submission

Recovery testing consumes significant effort from the analytical team, and even if the recovery is not really high but the method is accurate and precise and meeting the other validation parameters, we are proceeding with it


Kindly, share your opinions.


Thanks in advance :)