Bioequivalence and Bioavailability Forum

Hello Dr. Pravin!

Since at least gastric resistant lansoprazole is not a candidate for a biowaiver, following rules apply:

• If the combination is already marketed in the country you are aiming for application, you should demonstrate (in vivo-) BE to the reference kit (first approved product).
  
• If the combination is not yet marketed, you must demonstrate BE to a combination of the three single API products.

You should consult the Guidance page for specific informations.

Be prepared for a large sample size in a conventional 2×2 design or a replicate design study, since lansoprazole is a HVD...