Bioequivalence and Bioavailability Forum

Hi Sonu,

❝ Regarding the question, I would like to know how to perform and documents BE studies for the generic equivalents of Opthalmic and Otic suspensions. Further, If someone have the literature and guidance available with them, please provide the link for the same.

You do not write which market you are targeting. If you are going for EU/US, there is a risk that the necessary pivotal study is based on a pharmacodynamic endpoint rather than a pharmacokinetic. Things bare heading in that direction and regulators might play the assay sensitivity card, which can complicate the design a lot.
For EU, a PD trial would most likely imply submission under article 10.3 so it isn't a generic in the classical sense. A true generic should be possible in the US due to their definition of BE.

Best regards,
EM.