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Registershould sprinkle BE study be in fasting condition only or also in fed? [Regulatives / Guidelines]
Dear All:
In the FDA "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" guideline, it indicates that "If the label of a modified release RLD product states that the product can be administered sprinkled in soft foods, we recommend applicants conduct an additional BE study." and "Aside from administration in the soft food, this additional study should follow the recommendations for the fasting BE study described in the Appendix.".
Does that mean if RLD can be administered sprinkled with applesauce, the ANDA product should conduct an additional fasting sprinkle-in-applesauce BE study?
why do this additional BE study can be in fasting condition only? Does there have any evidence indicating that sprinkle BE study could not include fed condition?
Regards
chloe
In the FDA "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" guideline, it indicates that "If the label of a modified release RLD product states that the product can be administered sprinkled in soft foods, we recommend applicants conduct an additional BE study." and "Aside from administration in the soft food, this additional study should follow the recommendations for the fasting BE study described in the Appendix.".
Does that mean if RLD can be administered sprinkled with applesauce, the ANDA product should conduct an additional fasting sprinkle-in-applesauce BE study?
why do this additional BE study can be in fasting condition only? Does there have any evidence indicating that sprinkle BE study could not include fed condition?
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 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
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