Bioequivalence and Bioavailability Forum

Dear Osama,

❝ […] a Bio-equivalence study which was conducted by a reference drug that was given to the subjects at the last month of it's shelf-life …

Not optimal but still OK.

❝ … while the bio-analysis for the parent and it's active metabolites of this reference drug was happened after two months of expiration date of the reference drug.

❝

❝ Please enlighten me if this case of Bio-analysis can be accepted.

IMHO, yes (of course, if the long term stability of samples was validated).

• The reference was within its spec’s when it was administered.
  
• Once you deal with samples (parent / metabolites) only BMV is important. The fact that the drug expired in the meantime is not relevant.

A similar question was raised in discussing BMV. Say, stock solution stability was validated and the reference standard expired during the course of the study. Can CCs and QCs still be prepared from the stock solution? The answer was yes.
Only if a new stock solution has to be prepared, either a new reference standard should be obtained or the identity/purity of the old reference standard re-established.