BE study: modified vs immediate release [Design Issues]
Hi Helmut,
Thanks a lot for your reply.
Unfortunately I don't have specific guides for modified-release products therefore we ave to use EMA/FDA guides
But one more question - how do you understand section 6.1.1.2?
As far as I understand, having a new modified-release medication at first I have to conduct single-dose study to assess mean AUC0-t/AUC0-inf?
If this ratio <0.90 it says about accumulation and I have to conduct multi-dose study?
If this ratio >0.90 multi-dose study is not required and I can have some rest?
An I right?
Thanks a lot for your reply.
Unfortunately I don't have specific guides for modified-release products therefore we ave to use EMA/FDA guides

But one more question - how do you understand section 6.1.1.2?
As far as I understand, having a new modified-release medication at first I have to conduct single-dose study to assess mean AUC0-t/AUC0-inf?
If this ratio <0.90 it says about accumulation and I have to conduct multi-dose study?

If this ratio >0.90 multi-dose study is not required and I can have some rest?

An I right?

Complete thread:
- BE study: modified vs immediate release BE-proff 2015-07-28 19:15 [Design Issues]
- BE study: modified vs immediate release Helmut 2015-07-29 13:06
- BE study: modified vs immediate releaseBE-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