Bioequivalence and Bioavailability Forum

Hello Jasim.

❝ According to FDA regulations, the product "administered by inhalation as a gas, e.g., a medicinal or an inhalation anesthetic" does not require BE study.

A pMDI does not fall in this category since the active substance is not in gas form - it is just aerosolised. FDA is developing guidance in this field and they are quite strict. Read here for more information about the highly regulated markets.

❝ Should Chewable or Dispersible tablet require BE? Please share with me if you know about it.

Hehe, for the regulated markets, yes, quite often a BE study is needed. I am not ruling out that it works differently in other markets or that you can argue BCS class I and get biowaivers etc.