Multiple dose study for MR product in EU [Regulatives / Guidelines]
» Please elaborate or simplify the same for better understanding.
You can consider "first dose" as a "single dose" study.
For MR products in EMEA, first perform pivotal BE study under fasting state and evalaute 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.
You can refer following posts as well: #12612, #7062, #8296
Hope this info would be helpful.
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! [Helmut]