Bioequivalence and Bioavailability Forum • Multiple dose study for MR product in EU

Multiple dose study for MR product in EU [Regulatives / Guidelines]

posted by jalgorta - Spain, 2017-03-14 14:18 - Posting: # 17156
Views: 384
(edited by Ohlbe on 2017-03-14 17:37)

» For MR products in EMEA, first perform pivotal BE study under fasting state and evaluate the results. If AUC0-t>0.9*AUCinf, you need not to go ahead for steady state BE study. BE under steady state is required when drug accumulates in body. If AUC0-t> 0.9*AUCinf is achieved after signle dose administration, normally, there would not be accumulation.

Hi Samaya, you mention that "first perform pivotal BE under FASTING state"... My question is if you can confirm and reference that the calculation must be under fasting. Since in the case of modified release two conditions are necessary, should be FAST and/or FED???
Kind regards

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Multiple dose study for MR product in EU - Mahesh M, 2014-09-26 11:53 [Regulatives / Guidelines]
- Multiple dose study for MR product in EU - Samaya B, 2014-09-27 11:06
  - Multiple dose study for MR product in EU - jalgorta, 2017-03-14 14:18