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RegisterBio-equivalence of IR Tablet against ER Tablet [Design Issues]
Dear Sirs
Does anyone know about BE Study design of Immediate Release Formulation against Extended Release Formulation?
We manufacture Potassium Chloride 600 mg IR tablet. But no RLD is available as IR tablet. RLD SLOW-K 600 mg of Novartis is available as ER tablet.
Is it possible to design BE study of our IR formulation of Potassium Chloride 600 mg against SLOW-K 600 mg ER tablet?
Would appreciate kind advice of the experts in this forum.
Kind regards
Jasim
Edit: Category changed; see also this post #1. [Helmut]
Does anyone know about BE Study design of Immediate Release Formulation against Extended Release Formulation?
We manufacture Potassium Chloride 600 mg IR tablet. But no RLD is available as IR tablet. RLD SLOW-K 600 mg of Novartis is available as ER tablet.
Is it possible to design BE study of our IR formulation of Potassium Chloride 600 mg against SLOW-K 600 mg ER tablet?
Would appreciate kind advice of the experts in this forum.
Kind regards
Jasim
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Bio-equivalence of IR Tablet against ER TabletJasim Uddin 2018-06-20 13:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bio-equivalence of IR Tablet against ER Tablet Jasim Uddin 2018-06-24 10:28
Ing. Helmut Schütz