EXPERT APPROACHES TO EQUIVALENCE EVALUATION OF DRUGS — ANALOGUES OF ENDOGENOUS COMPOUNDS AS CONSISTENT WITH THE RUSSIAN LEGISLATION AND INTERNATIONAL LAW
The article demonstrates that bioequivalence studies of generic drugs whose active substances are analogues of endogenous compounds found in the human body in natural concentrations present a major challenge as compared to other products and call for a specific regulatory approach. In the absence of...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
NEICON ISP LLC
2018-03-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/150 |