Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2019-04-14 12:56  – Posting: # 20158
Views: 1,540

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).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.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
20,258 posts in 4,264 threads, 1,397 registered users;
online 25 (1 registered, 24 guests [including 1 identified bots]).
Forum time (Europe/Vienna): 21:31 CET

You should treat as many patients as possible with the new drugs
while they still have the power to heal.    Armand Trousseau

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5