Bioequivalence and Bioavailability Forum

❝ Some time there are instances in bioequivalence where one of the 90%

❝ confidence limit is not falling in the range (80%- 125%), so in this

❝ situation can bioequivalence be concluded?

Yes for all BE Study You have to conclude the Bioequivalence. If it is not falling in the range then it (test with reference) will be not bioequivalent

❝ And how many PK parameters (AUC, Cmax, tmax) are required to conclude the

❝ bioequivalence

For most of the countries it is concluded on primary parameters

❝ or can we make conclusion of bioequivalence only on the basis of AUC?

No, you can't give the conclusion on the basis on only AUC.
If you have any question pls. revert me

Regards
Bharat