Difference between tablet and film tablet [Regulatives / Guidelines]
Hi wienui,
Since a film coat usually does not modify the release, this might be a situation where you can argue to use just dissolution. Show that the fc tablets behave like the ordinary tablet.
❝ I have a question regarding to the Bioequivalence (BE) study of IR tablets vs IR Film coated (F.C.) tablets.
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❝ if the BE study is done for the IR Tablets formulation and the manufacture want to register the IR Film coated tablets formulation, should he need to conduct a new BE study for this formulation?
❝ what I think is that the Pk behaviour for the two formulations ( especially the absorption process) will be totally different which could definitely different consequences of therapeutic effect. Please correct me if I'm wrong.
Since a film coat usually does not modify the release, this might be a situation where you can argue to use just dissolution. Show that the fc tablets behave like the ordinary tablet.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Difference between tablet and film tablet vivekanand 2012-11-16 11:16 [Regulatives / Guidelines]
- Difference between tablet and film tablet ElMaestro 2012-11-16 13:24
- Difference between tablet and film tablet wienui 2015-11-24 18:46
- Difference between tablet and film tabletElMaestro 2015-11-24 22:01
- Difference between tablet and film tablet AngusMcLean 2015-12-03 03:25
- Difference between tablet and film tabletElMaestro 2015-11-24 22:01
- Difference between tablet and film tablet wienui 2015-11-24 18:46
- Difference between tablet and film tablet ElMaestro 2012-11-16 13:24