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RegisterSprinkle study in IR formulation [Regulatives / Guidelines]
Dear Compliance,
For immediate-release (IR) drug products labeled for sprinkle, it is generally not necessary to conduct a sprinkle BE study, as the expectation would be that the sprinkles would behave similarly for the test and RLD IR products.
Regards
Mahesh
For immediate-release (IR) drug products labeled for sprinkle, it is generally not necessary to conduct a sprinkle BE study, as the expectation would be that the sprinkles would behave similarly for the test and RLD IR products.
Regards
Mahesh
Complete thread:
- Sprinkle study in IR formulation Compliance 2014-03-19 05:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sprinkle study in IR formulationMahesh M 2014-03-19 11:35
- Sprinkle study in IR formulation Dr_Dan 2014-03-19 11:51
- Sprinkle study in IR formulation Compliance 2014-03-20 07:05
- Sprinkle study in IR formulation jag009 2014-03-20 16:35
- Sprinkle study in IR formulation Compliance 2014-03-20 07:05
Ing. Helmut Schütz