Bioequivalence and Bioavailability Forum

❝ We would like to know what kind of studies required for Mesalazine Gastro-resistant MR tablets for Europe Market.

Dear Kotu,

Since it has enteric coated form most probably it will require semi or fully replicate design but to decide it better to perform a pilot study with 18 sub at least to have a meaningful results. as per literature sources ISCV >30%

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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]