Bioequivalence and Bioavailability Forum • Expiration of Reference drug during Bioanalysis

Expiration of Reference drug during Bioanalysis [Bioanalytics]

posted by jag009 – NJ, 2019-04-15 04:51 (650 d 11:05 ago) – Posting: # 20160
Views: 2,826

Hi,

» 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...

I had the issue 2 times before w FDA studies. As long as dosing is done there shouldn't be any issues. My studies completed dosing a week before the RLD expiry date.

J

Complete thread:

Expiration of Reference drug during Bioanalysis wienui 2019-04-14 11:51 [Bioanalytics]
- Expiration of Reference drug during Bioanalysis Helmut 2019-04-14 12:56
- Expiration of Reference drug during Bioanalysisjag009 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