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RegisterWidened acceptance range w. a 2,2,2-study? [Regulatives / Guidelines]
Dear both
the procedure was finalized one year ago, October 6th 2010. Although at that time the new BE guideline was finalized it is very unlikely that this NfG was taken into considerations. I guess the study was conducted in 2009 according to the old guideline and the Q&A 2006 document. In contrast to immediate release oral formulations the applicant performed three studies for a modifies release formulation and based on the results of all three studies the assessor judged the product to be bioequivalent to the reference even if the tighter acceptance range in one study was not met. Fed studies are known to have a higher variability. I assume the applicant agreed with this decision. However, it will be hard for a competitor to claim the same.
Kind regards
Dan
the procedure was finalized one year ago, October 6th 2010. Although at that time the new BE guideline was finalized it is very unlikely that this NfG was taken into considerations. I guess the study was conducted in 2009 according to the old guideline and the Q&A 2006 document. In contrast to immediate release oral formulations the applicant performed three studies for a modifies release formulation and based on the results of all three studies the assessor judged the product to be bioequivalent to the reference even if the tighter acceptance range in one study was not met. Fed studies are known to have a higher variability. I assume the applicant agreed with this decision. However, it will be hard for a competitor to claim the same.
Kind regards
Dan
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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