Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by wienui  – Germany/Oman, 2019-04-14 11:51 (1213 d 18:41 ago) – Posting: # 20157
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(edited by wienui on 2019-04-14 12:09)

Dear All,

I face a situation in the evaluation of 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 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.

Best regards,
Osama

Cheers,
Osama

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