Bioequivalence and Bioavailability Forum

Thanks for your response.

According to link shared by you mentioned as
“Dose linearity should be investigated in vitro for both the test and the reference product across all proposed strengths.
If dose linearity is demonstrated in vitro when different dose strengths of a known active substance are sought it may be sufficient to establish therapeutic equivalence clinically with only one strength of the active substance. It is usually appropriate to study the lowest strength, at more than one dose level, to enhance the sensitivity of the study.”

Therapeutic equivalence term use for Pharmacodynamic study or Clinical end point study on patient ?

Regards