Results for bioequivalent translation from English to Russian

drug bioequivalent
bioekvivalentnost'

in many countries, a subsequent generic manufacturer who seeks approval to market the generic equivalent is not required to submit fresh clinical test data but can show that its medicine is bioequivalent to the medicine of the originator company.
Во многих странах от последующих производителей генерических продуктов, запрашивающих разрешение на сбыт генерического эквивалента того или иного лекарства, не требуется представлять свежие данные о клинических испытаниях, но они могут демонстрировать, что разработанные ими лекарства являются биоэквивалентом лекарства, выпускаемого компанией-создательницей.

=== europe ===according to regulations applicable in the european economic area two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, will be essentially the same.
=== europe ===according to european regulations emea-cpmp, note for guidance on the investigation of bioavailability and bioequivalence, london, july 2001 cpmp/ewp/qwp/1401/98 two medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, will be essentially the same.