Bioequivalence and Bioavailability Forum

Dear VP,

i think its better practice to start the subject sample analysis after the QA review of the method validation.

If the study is for european region, i may caution you, as we had an experience of getting the observation for the same issue from an european regulatory authority.

regarding the reference, it may be a better GLP practice of having full confidence and certification (from your independent QA) of your method performance before starting the subject sample analysis.

for the documentation, all depends on what your SOP says about your procedures/practices.

Regards,

Debbie