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Dear Detlew:
In the sprinkle BE study, the food (like applesauce or other soft food) administered with sprinkles is just a substance to assist patients to swallow drug products. Unlike fed studies test meal (high-fat, high-calorie), The amount of these soft food is very small, often just a spoonful.
In the FDA guideline, the sprinkle BE study should follow the recommendations for fasting BE study.
-
regards
chloe
In the sprinkle BE study, the food (like applesauce or other soft food) administered with sprinkles is just a substance to assist patients to swallow drug products. Unlike fed studies test meal (high-fat, high-calorie), The amount of these soft food is very small, often just a spoonful.
In the FDA guideline, the sprinkle BE study should follow the recommendations for fasting BE study.
-
regards
chloe
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 fastchloe 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