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RegisterMultiphasic MR ≠ DR [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2012-03-09 13:18 (4811 d 16:52 ago) – Posting: # 8241
Views: 22,587
Dear Luv!
No. This is a delayed release formulation.
Not uncommon for PPIs. Sometimes physiology plays havoc with formulations.
No cut-off, no pAUCs. See the guidance – only conventional FDA's metrics: AUC0-t, AUC0-∞, Cmax. If you are able to show high variability in a replicate design study you are allowed to scale (both AUCs and Cmax).
AFAIK FDA has issued only two product specific guidances for “pAUC BE Metrics for Multiphasic MR Formulations”: zolpidem ER tablets and methylphenidate ER capsules.
Well, I consider myself an ‘original scientist’.
❝ Does that mean that the same would be applicable to Dexlansoprazole DR capsules as well???
No. This is a delayed release formulation.
❝ What about varying rate of gastric emptying??
❝ We have done a few studies on the said molecule and the first peak comes at 3 hr (range 30 min to 5 hrs and second at 6 hrs (3-8 hrs) and the main reason was varying gastric emptying??
Not uncommon for PPIs. Sometimes physiology plays havoc with formulations.
❝ Then what should be the cut off time????
❝ You fix any cut off time and you will surely fail for partial AUC!!!!
No cut-off, no pAUCs. See the guidance – only conventional FDA's metrics: AUC0-t, AUC0-∞, Cmax. If you are able to show high variability in a replicate design study you are allowed to scale (both AUCs and Cmax).
AFAIK FDA has issued only two product specific guidances for “pAUC BE Metrics for Multiphasic MR Formulations”: zolpidem ER tablets and methylphenidate ER capsules.
❝ Life of a generic scientist is getting tougher day by day!!!!!
Well, I consider myself an ‘original scientist’.
—
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- EMA: Q&A on biphasic MR products Helmut 2012-03-06 15:23 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
- EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-07 19:20
- EMA: Q&A on biphasic MR products Helmut 2012-03-07 03:52
- EMA vs. FDA d_labes 2012-03-07 10:26
- MPH examples Helmut 2012-03-07 14:22
- MPH examples d_labes 2012-03-07 16:18
- MPH examples Helmut 2012-03-08 01:07
- FDA more straight? d_labes 2012-03-08 08:29
- and what about power? ElMaestro 2012-03-08 11:37
- and what about power? d_labes 2012-03-08 13:26
- and what about power? Helmut 2012-03-08 13:36
- FDA more straight? Helmut 2012-03-08 12:51
- FDA more straight? luvblooms 2012-03-09 06:55
- Multiphasic MR ≠ DRHelmut 2012-03-09 12:18
- Multiphasic MR ≠ DR jag009 2012-03-28 15:29
- Metadate CD (30/70) Helmut 2012-03-28 15:45
- Multiphasic MR ≠ DR jag009 2012-03-28 15:29
- Multiphasic MR ≠ DRHelmut 2012-03-09 12:18
- FDA more straight? luvblooms 2012-03-09 06:55
- and what about power? ElMaestro 2012-03-08 11:37
- FDA more straight? d_labes 2012-03-08 08:29
- MPH examples Helmut 2012-03-08 01:07
- MPH examples d_labes 2012-03-07 16:18
- MPH examples Helmut 2012-03-07 14:22
- EMA: Q&A on biphasic MR products ElMaestro 2012-03-06 19:09
Ing. Helmut Schütz