Clarification from Russian expert organization regarding telmisartan BE studies [Regulatives / Guidelines]

posted by Mikalai  – Belarus, 2019-12-09 18:27  – Posting: # 20968
Views: 1,261

»     2. Not only males should be enrolled but females as well (50/50).

This is a rather dubious approach:cool:. We test bioequivalence only in the healthy but do not usually in the elderly, the sick, those with renal and liver problems and etc. But we do expand the results of our studies to the aforementioned groups. Moreover, in Russia, bioequivalence studies are usually conducted in relatively young people, less than 50 years old, usually. This is barely a target population. Absolute numbers of PK parameters may differ, but it is very unlikely that the PK of products may differ to bioeinequivalence unless we have information about substantial variability in a specific group. In addition, I saw many trials with only male subjects done in India. They were registered in Europe. But personally, I have not encountered that they were later withdrawn from the market because they were found less efficacious and/or more dangerous in a specific gender or another group. Unfortunately, experts from CIS are infamously known because of their rather questionable and unscientific approaches to BE studies and the registration process.
Also, our population is so so so so different that studies can be done only within the Eurasian Economic Union:-D.

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