Bioequivalence and Bioavailability Forum

Dear Mr Mahesh,

❝ Is it required to perform BE on all strength of orally inhaled products (OIPs)? Can any one suggest references or guideline for the same?

In cases where different dose strengths of the same product containing a well-known active substance are sought, it can be sufficient to state the therapeutic equivalence clinically in vivo with one of those dose strengths. Thereafter it is necessary to give proof of a linear dose deposition relationship in vitro for each of the other dose strengths performed with a multistage impactor

Reference: EMA’s Points to consider on the requirements for clinical documentation for orally inhaled products (OIP)