Bioequivalence and Bioavailability Forum

Dear Member,

I need your expert advice in following:

"what would be the agency's look out if single ANDA contains two different method for subject sample analysis at two different site (any of the study condition i.e. fast or fed on different method).

Method contains same range but having difference in the extraction process (i.e. SPE Vs. LLE)and mobile phase composition".

please share your expert thoughts on this and help me in such situation.

Regards,

Compliance