Bioequivalence and Bioavailability Forum

Hi Khaoula,

the guidance you are referring to is 22 years old and obsolete. HC removed the dose correction already in the 2009 draft. This part of the current guidance is harmonized with EMA’s and FDA’s requirements.

According to EMA you can apply a dose-correction if you have evidence that it was not possible to find a batch of the reference which does not differ ≤±5% to the test. The intention to use a dose-cor­rec­tion has to be stated and justified in the protocol. Switching after the study was performed is not acceptable. “This is the reference I got in the pharmacy next door” is not a justification.

FDA no idea.