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RegisterNo “dissolution” of a solution… [Regulatives / Guidelines]
Dear Helmut,
Unlike comparison with solid oral dosage form, comparative bioavailability studies are a nightmare! We once did a study with liquid filled capsule vs tablets which failed (esp with Cmax)... no way we could design formulation which can have Cmax satisfying BE criteria especially between our tablets vs the liquid filled capsule and had to discontinue further development.
Hybrid application though sounds different often has a BA/BE study difficult to achieve bioequivalence.
As far as dosing the oily solution is concerned, adequate volume of solution will be given to match the quantity of active ingredient in the comparator tablets!
Kind regards,
Tina
Unlike comparison with solid oral dosage form, comparative bioavailability studies are a nightmare! We once did a study with liquid filled capsule vs tablets which failed (esp with Cmax)... no way we could design formulation which can have Cmax satisfying BE criteria especially between our tablets vs the liquid filled capsule and had to discontinue further development.
Hybrid application though sounds different often has a BA/BE study difficult to achieve bioequivalence.
As far as dosing the oily solution is concerned, adequate volume of solution will be given to match the quantity of active ingredient in the comparator tablets!
Kind regards,
Tina
Complete thread:
- BE study-oily solution vs tablets Tina 2013-10-03 12:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- No dissolution? Helmut 2013-10-03 13:01
- No dissolution? Tina 2013-10-03 13:16
- No “dissolution” of a solution… Helmut 2013-10-03 13:35
- No “dissolution” of a solution…Tina 2013-10-03 15:10
- No “dissolution” of a solution… Helmut 2013-10-03 13:35
- No dissolution? Tina 2013-10-03 13:16
- No dissolution? Helmut 2013-10-03 13:01
Ing. Helmut Schütz