Bioequivalence and Bioavailability Forum

Hi all,

Greetings!

I would like to request clarification regarding BE guidelines CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **. Request you to please advice if the general Biowaiver criteria, should be applied to the additional strengths that require waiving only or should the higher/lower strength on which BE needs to be performed also need to comply with the biowaiver criteria?

For eg., and to be more specific, the condition "C" states that the composition of the other strengths should be quantitatively proportional. Deviation of the same provides other conditions of which the condition 1 (mandatory condition) that the amount of active substance is less than 5% of the core weight/fill weight.

Please advice if this condition applies to the strength on which BE will be performed or should this be applied to only additional strengths that need to be waived?

And if the BE strength does not comply with this condition and contains active substance more than 5%, can we still proceed with applying the biowaiver criteria??

Thank you so much in advance for your kind advice!

Regards,
Gopal