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Registershould sprinkle BE study be in fasting condition only or also in fed? [Regulatives / Guidelines]
Hi,
At least in most (if not all guidances) I have read.
John
❝ Does that mean if RLD can be administered sprinkled with applesauce, the ANDA product should conduct an additional fasting sprinkle-in-applesauce BE study?
At least in most (if not all guidances) I have read.
John
Complete thread:
- should sprinkle BE study be in fasting condition only or also in fed? chloe 2016-04-27 04:44 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- To fast or not to fast d_labes 2016-04-27 07:50
- To fast or not to fast chloe 2016-04-27 08:59
- should sprinkle BE study be in fasting condition only or also in fed?jag009 2016-05-09 23:14
- To fast or not to fast d_labes 2016-04-27 07:50
Ing. Helmut Schütz