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