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RegisterSprinkle study in IR formulation [Regulatives / Guidelines]
Dear All,
As per the draft guidance on PK study (US FDA) sprinkle study is suggested for modified release formulation. Now my question is what to do if the label of IR formulation suggest to do the sprinkle study which is not cover in draft guidance. (I am going to conduct study of Celecoxib 400 mg and RLD is Celebrex).
Regards,
Compliance
As per the draft guidance on PK study (US FDA) sprinkle study is suggested for modified release formulation. Now my question is what to do if the label of IR formulation suggest to do the sprinkle study which is not cover in draft guidance. (I am going to conduct study of Celecoxib 400 mg and RLD is Celebrex).
Regards,
Compliance
Complete thread:
- Sprinkle study in IR formulationCompliance 2014-03-19 05:12
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sprinkle study in IR formulation Mahesh 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