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RegisterODT vs. IR [Regulatives / Guidelines]
Dear All,
could you you help me with EMA guideline understanding at this part:
"If the ODT test product is an extension to another oral formulation, a 3-period study is recommended in order to evaluate administration of the orodispersible tablet both with and without concomitant fluid intake. However, if bioequivalence between ODT taken without water and reference formulation with water is demonstrated in a 2-period study, bioequivalence of ODT taken with water can be assumed."
What does it mean?
"We recommend you to perform 3-period study. By the way you can perform simple 2-period study and it's enough"
Who will perform complex 3-period study in the presence of simple solution?
could you you help me with EMA guideline understanding at this part:
"If the ODT test product is an extension to another oral formulation, a 3-period study is recommended in order to evaluate administration of the orodispersible tablet both with and without concomitant fluid intake. However, if bioequivalence between ODT taken without water and reference formulation with water is demonstrated in a 2-period study, bioequivalence of ODT taken with water can be assumed."
What does it mean?
"We recommend you to perform 3-period study. By the way you can perform simple 2-period study and it's enough"
Who will perform complex 3-period study in the presence of simple solution?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- ODT vs. IRmittyri 2014-03-08 15:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ODT vs. IR jag009 2014-03-10 19:01
- ODT vs. IR Dr_Dan 2014-03-10 19:36
- ODT vs. IR mittyri 2014-03-14 10:05
- ODT vs. IR fno 2014-03-14 14:51
- ODT vs. IR Dr_Dan 2014-03-17 10:30
- ODT vs. IR fno 2014-03-17 12:18
- ODT vs. IR Dr_Dan 2014-03-17 10:30
Ing. Helmut Schütz