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RegisterTeriminal partial AUC for Metformin ER Tablets [Regulatives / Guidelines]
Hi,
Partial AUC assessment is for products with multiphasic drug delivery system (in USA, ie: Concerta, Ritalin LA, Adderall XR, Zolpidem). These products are designed to release drugs in two phases, an IR and an ER burst, for disease treatment strategies. Due to the clinical relevance of the drug release profile, partial AUCs are required to ensure that the generics yield similar drug exposures in the IR and ER portion of the profile relative to the innovator. importance As far as I know Metformin ER does not have such delivery system so Partial AUC is not really need. I ran metformin ER studies in the US and no partial AUCs were needed.
It seems like the EMA statement you quoted is a general statement and is not product specific.
John
Partial AUC assessment is for products with multiphasic drug delivery system (in USA, ie: Concerta, Ritalin LA, Adderall XR, Zolpidem). These products are designed to release drugs in two phases, an IR and an ER burst, for disease treatment strategies. Due to the clinical relevance of the drug release profile, partial AUCs are required to ensure that the generics yield similar drug exposures in the IR and ER portion of the profile relative to the innovator. importance As far as I know Metformin ER does not have such delivery system so Partial AUC is not really need. I ran metformin ER studies in the US and no partial AUCs were needed.
It seems like the EMA statement you quoted is a general statement and is not product specific.
John
Complete thread:
- Teriminal partial AUC for Metformin ER Tablets Naveen Kumar 2014-09-10 12:34 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Teriminal partial AUC for Metformin ER Tablets jag009 2014-09-10 19:51
- Teriminal partial AUC for Metformin ER Tablets Naveen Kumar 2014-09-11 06:15
- Teriminal partial AUC for Metformin ER Tabletsjag009 2014-09-11 20:07
- Epilim Chrono 500 CR tablets kumarnaidu 2014-10-13 12:39
- Teriminal partial AUC for Metformin ER Tabletsjag009 2014-09-11 20:07
- Teriminal partial AUC for Metformin ER Tablets Naveen Kumar 2014-09-11 06:15
- Teriminal partial AUC for Metformin ER Tablets jag009 2014-09-10 19:51
Ing. Helmut Schütz