Expiration of Reference drug during Bioanalysis [Bioanalytics]
❝ […] 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.
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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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