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RegisterBA study of one SR formulation with 2 IR tab. [Regulatives / Guidelines]
Dear all,
I am intrested in knowing about conduct of "bioavailability studies comparing 1 sustained release tablet versus 2 immediate release tablets (dosed twice)". The SR tablet (e.g.: strength 20 mg) is dosed once while the IR tablet is dosed twice i.e. 1st 10 mg IR tablet at the time when 20 mg of SR tab is dosed and 2nd 10 mg IR tablet 12 hours after dosing.
Please explain?
Taresh
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Edit: Please don't use capital letters only - bold format is enough (see the Policy). [Helmut]
I am intrested in knowing about conduct of "bioavailability studies comparing 1 sustained release tablet versus 2 immediate release tablets (dosed twice)". The SR tablet (e.g.: strength 20 mg) is dosed once while the IR tablet is dosed twice i.e. 1st 10 mg IR tablet at the time when 20 mg of SR tab is dosed and 2nd 10 mg IR tablet 12 hours after dosing.
Please explain?
- Need of comparing SR formulation with a IR formulation?
- Are there any regulatory guidances which give the procedure for conduct for this study?
- How do we report such type of studies?
Taresh
--
Edit: Please don't use capital letters only - bold format is enough (see the Policy). [Helmut]
Complete thread:
- BA study of one SR formulation with 2 IR tab.taresh41 2009-06-24 08:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Homework Jaime_R 2009-06-24 13:22
- BA study of 1 SR tablet versus 2 IR tablets. taresh41 2009-06-25 07:27
- Search Guidelines first! Jaime_R 2009-06-25 10:07
- BA of 1 SR tablet versus 2 IR tablets taresh41 2009-06-25 13:26
- Search Guidelines first! Jaime_R 2009-06-25 10:07
- BA study of 1 SR tablet versus 2 IR tablets. taresh41 2009-06-25 07:27
- Homework Jaime_R 2009-06-24 13:22
Ing. Helmut Schütz