Optimisation of Approaches to Adverse Event Analysis in Bioequivalence Clinical Trials

• Autori principali: A. B. Verveda (Autore), V. B. Vasilyuk (Autore), G. I. Syraeva (Autore), M. V. Faraponova (Autore)
• Natura: Libro
• Pubblicazione: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2024-04-01T00:00:00Z.
• Soggetti: article
• Accesso online: Connect to this object online.

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...