Log in
RegisterAdverse events [General Statistics]
Dear all
an assessor realized that the number of AEs differ between the treatment groups and he/she concluded that the tolerability of one product is worse than the other.
I would reply that bioavailability in terms of peak and total exposure is taken as a surrogate parameter for efficacy and safety and I would point out that bioequivalence studies are not designed to investigate the safety profile in terms of AEs of one formulation in comparison to another. Due to the small numbers of subjects and small number of AEs any differences become significant but statistically not relevant.
Is this correct or do you have other suggestions?
Looking forward to your replies.
Kind regards
Dan
an assessor realized that the number of AEs differ between the treatment groups and he/she concluded that the tolerability of one product is worse than the other.
I would reply that bioavailability in terms of peak and total exposure is taken as a surrogate parameter for efficacy and safety and I would point out that bioequivalence studies are not designed to investigate the safety profile in terms of AEs of one formulation in comparison to another. Due to the small numbers of subjects and small number of AEs any differences become significant but statistically not relevant.
Is this correct or do you have other suggestions?
Looking forward to your replies.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Adverse eventsDr_Dan 2011-09-01 11:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Significant differences in AEs Helmut 2011-09-01 12:18
- Significant differences in AEs Dr_Dan 2011-09-01 15:44
- Significant differences in AEs ElMaestro 2011-09-01 13:40
- Adverse events ElMaestro 2011-09-01 18:12
- Adverse events martin 2011-09-02 11:02
- Significant differences in AEs Helmut 2011-09-01 12:18
Ing. Helmut Schütz