Optimisation of Approaches to Adverse Event Analysis in Bioequivalence Clinical Trials
SCIENTIFIC RELEVANCE. The safety assessment of investigational medicinal products is a mandatory step in clinical trials of all phases, including bioequivalence studies. However, there are no approaches providing for the individualised assessment of adverse drug reactions (ADRs), which contributes t...
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| Main Authors: | , , , |
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| Format: | Book |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»,
2024-04-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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