Bioequivalence and Bioavailability Forum

Dear Soma!

❝ How one can know whether any BA/BE study fails due to error in formulation

❝ preparation ?

Oops! I hope you are talking about a (few) suspected case(s) in a study.
Conformity with cGMP is a prerequisite of BE! You may suspect anything, but:

• If you are able to track down an error in the preparation of IPs, fine, but I would expect your chances to remove these suspects after the study was unblinded and evaluated to be very low.
  
• If you don't find the error (=documented: no oral lore!), your chances are close to nil.

In either case it casts a damning light on the conformity with cGMPs. Even if the study is accepted - which I don't believe - prepare for a thorough cGMP/GCP inspection soon.