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RegisterBE in orodispersible tablets [Design Issues]
Dear Dan,
Would be easier, but I'm not sure the BE guideline is really giving you that choice:
if the reference medicinal product can be taken with or without water, bioequivalence should be demonstrated without water as this condition best resembles the intended use of the formulation. This is especially important if the substance may be dissolved and partly absorbed in the oral cavity. If bioequivalence is demonstrated when taken without water, bioequivalence when taken with water can be assumed.
Regards
Ohlbe
❝ If the originator SmPC tells me that the ODT can also be taken as an oral suspension I think then I should prefer this kind of application, right?
Would be easier, but I'm not sure the BE guideline is really giving you that choice:
if the reference medicinal product can be taken with or without water, bioequivalence should be demonstrated without water as this condition best resembles the intended use of the formulation. This is especially important if the substance may be dissolved and partly absorbed in the oral cavity. If bioequivalence is demonstrated when taken without water, bioequivalence when taken with water can be assumed.
Regards
Ohlbe
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- BE in orodispersible tablets Dr_Dan 2011-04-11 10:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE in orodispersible tablets ElMaestro 2011-04-11 10:24
- BE in orodispersible tablets Dr_Dan 2011-04-11 15:32
- BE in orodispersible tablets ElMaestro 2011-04-11 17:10
- BE in orodispersible tabletsOhlbe 2011-04-11 23:01
- BE in orodispersible tablets Dr_Dan 2011-04-11 15:32
- BE in orodispersible tablets ElMaestro 2011-04-11 10:24
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