Relevant Issues of Planning Bioequivalence Studies of Drugs with a Narrow Therapeutic Range
In order to be registered, generic drugs with a narrow therapeutic range have to undergo bioequivalence or therapeutic equivalence studies. In most cases, comparative pharmacokinetic studies and demonstration of bioequivalence between the test and the reference products are sufficient for this group...
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Format: | Article |
Language: | Russian |
Published: |
OOO “Vashe Tsifrovoe Izdatelstvo”
2020-09-01
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Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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Online Access: | https://www.vedomostincesmp.ru/jour/article/view/315 |