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RegisterBE study: modified vs immediate release [Design Issues]
Dear All,
May be my question will seem stupid but nevertheless I ask it.
I have to demonstrate BE between modified release product (taken once a day) and immediate-release product (taken twice a day).
IMHO there is a risk that both product can show different kinetics and they won't be equivalent in 1-time administration of each medications.
To avoid this risk I think of steady state study.
But how to prove my idea based on actual guides?
Does anybody have such experience?
May be my question will seem stupid but nevertheless I ask it.
I have to demonstrate BE between modified release product (taken once a day) and immediate-release product (taken twice a day).
IMHO there is a risk that both product can show different kinetics and they won't be equivalent in 1-time administration of each medications.
To avoid this risk I think of steady state study.
But how to prove my idea based on actual guides?
Does anybody have such experience?
Complete thread:
- BE study: modified vs immediate releaseBE-proff 2015-07-28 19:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study: modified vs immediate release Helmut 2015-07-29 13:06
- BE study: modified vs immediate release BE-proff 2015-07-30 08:27
- MR = twilight zone in Russia mittyri 2015-07-29 21:49
- MR = twilight zone in Russia BE-proff 2015-07-30 08:10
- MR vs. Russian experts mittyri 2015-07-30 11:04
- MR vs. Russian experts BE-proff 2015-07-30 11:46
- MR vs. Russian experts mittyri 2015-07-30 15:23
- MR vs. Russian experts BE-proff 2015-07-30 11:46
- MR vs. Russian experts mittyri 2015-07-30 11:04
- MR = twilight zone in Russia BE-proff 2015-07-30 08:10
- BE study: modified vs immediate release Helmut 2015-07-29 13:06
Ing. Helmut Schütz