Log in
RegisterCI outside 80.00%–125.00%, who cares? [Regulatives / Guidelines]
Dear Helmut
To be honest, we submitted this year a bioequivalence study for an IR formulation of a well known uncomplicated drug with following results:
upper confidence interval limit for Cmax slightly out of acceptance range
Results for AUC and Cmax ratios opposit => complete different kinetic in comparison to the originator
Point estimator shows a difference > 15% => narrow confidence interval due to high subject number and very low intra-subject variability.
I was convinced that we would have been slaughtered by the regulatory authorities, but what a surprise we got the marketing authorisation. RMS = Germany (BfArM). In fact the assessor did not care about the acceptance criteria layed down in the guideline. He just judged the clinical impact. So we are far away from a consistent assessment.
Kind regards
Dan
❝ → 80.00–125.00 ![/b]
❝ Cave: Keine Einreichung wenn Grenzen
❝ überschritten → EU weit: null Akzeptanz !!
❝ Of course this deals with IR, but nice to know.
To be honest, we submitted this year a bioequivalence study for an IR formulation of a well known uncomplicated drug with following results:
upper confidence interval limit for Cmax slightly out of acceptance range
Results for AUC and Cmax ratios opposit => complete different kinetic in comparison to the originator
Point estimator shows a difference > 15% => narrow confidence interval due to high subject number and very low intra-subject variability.
I was convinced that we would have been slaughtered by the regulatory authorities, but what a surprise we got the marketing authorisation. RMS = Germany (BfArM). In fact the assessor did not care about the acceptance criteria layed down in the guideline. He just judged the clinical impact. So we are far away from a consistent assessment.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Widened acceptance range w. a 2,2,2-study? ElMaestro 2011-10-09 13:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Widened acceptance range w. a 2,2,2-study? Helmut 2011-10-09 16:40
- Widened acceptance range w. a 2,2,2-study? Dr_Dan 2011-10-10 12:01
- Quot licet Iovi, non licet bovi Helmut 2011-10-10 12:57
- Cmax of interest? Dr_Dan 2011-10-10 16:57
- CI outside 80.00%–125.00% Helmut 2011-10-10 18:23
- CI outside 80.00%–125.00%, who cares?Dr_Dan 2011-10-11 09:54
- Common sense rulez?! Helmut 2011-10-11 16:27
- CI outside 80.00%–125.00%, who cares?Dr_Dan 2011-10-11 09:54
- CI outside 80.00%–125.00% Helmut 2011-10-10 18:23
- Cmax of interest? Dr_Dan 2011-10-10 16:57
- Quot licet Iovi, non licet bovi Helmut 2011-10-10 12:57
- Widened acceptance range w. a 2,2,2-study? Dr_Dan 2011-10-10 12:01
- Widened acceptance range w. a 2,2,2-study? Helmut 2011-10-09 16:40
Ing. Helmut Schütz