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RegisterExpiration of Reference drug during Bioanalysis [Bioanalytics]
Hi,
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
❝ 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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
- Expiration of Reference drug during Bioanalysis wienui 2019-04-18 10:04
- Expiration of Reference drug during Bioanalysis Helmut 2019-04-16 13:20
Ing. Helmut Schütz