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

posted by Samaya B - India, 2014-09-27 11:06  - Posting: # 13599
Views: 1,879

» "A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected".
» Please elaborate or simplify the same for better understanding.

Dear Mahesh,

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]

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