BE study: modified vs immediate release [Design Issues]

posted by BE-proff – 2015-07-30 10:27 (3480 d 21:13 ago) – Posting: # 15172
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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? :confused:
If this ratio >0.90 multi-dose study is not required and I can have some rest? :smoke:

An I right? ;-)

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