Bioequivalence and Bioavailability Forum

Dear All,

We are trying to do a BE Study with Clinical Endpoint for an Suspension/Drops, Ophthalmic.

Could anybody please suggest what are the parameters to be taken to calculate a sample size for this type of study?

For example please find the below link for a drug name and the type of study:

BE study with clinical end point

Moreover, Please give reference if any guideline on Ophthalmic drugs for USFDA or EMEA regulatory.

Thanks in advance.