Bioequivalence and Bioavailability Forum • Expiration of Reference drug during Bioanalysis

Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by wienui – Germany/Oman, 2019-04-14 13:51 (2232 d 09:55 ago) – Posting: # 20157
Views: 7,431

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

Complete thread:

Expiration of Reference drug during Bioanalysiswienui 2019-04-14 11:51
- Expiration of Reference drug during Bioanalysis Helmut 2019-04-14 12:56
- Expiration of Reference drug during Bioanalysis jag009 2019-04-15 06:51
- Expiration of Reference drug during Bioanalysis wienui 2019-04-15 20:58
  - Expiration of Reference drug during Bioanalysis Helmut 2019-04-16 13:20
    - Expiration of Reference drug during Bioanalysis wienui 2019-04-18 10:04
      - OT: Regulatory persons d_labes 2019-04-20 20:46