Bioequivalence and Bioavailability Forum

Hi all,

Anyone with experience showing BE for nasal sprays for EMA?

Are all 3 of:

• in vitro analyses
  
• PK
  
• therapeutic equivalence

required for a generic product to be accepted on the market?

There is a guidance discussing all in vitro assays required for EMA, but nothing on what in vivo studies must (also) be performed. I would appreciate any guidance, especially if based on experience.

Thank you.