Belarus = member of the EEU [Regulatives / Guidelines]

posted by Mikalai  – Belarus, 2018-01-04 20:49 (2329 d 21:47 ago) – Posting: # 18142
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Dear Helmut,
Thank you very much.

Yes, we plan to use the "staggered approach". We used to plan the replicative design, but a large dropout was observed during our last bioequivalence study (crossover design but with long blood sampling interval) due to completely unrelated to the study reasons. Thus, the company decided to put on hold the replicative design given that a clinical center can accommodate only a bit more than 35 volunteers.

We are opting for the model III and will try to use the FDA requirements to justify the statistical model in the protocol. Bioequivalence studies done in accordance with international standards are relatively new for Belarus. As a result, experience, training, and lore are issues for major players (manufacturers, regulators, clinical investigators). We also cannot run studies outside the Eurasian Economic Union. Thus, from time to time our regulators have to rely on opinions of more experienced colleagues, mainly from EMA and FDA. If they see that something is acceptable in Europe or the USA, they usually give us a green light. That why we need papers or proper references.

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