Optimisation of Approaches to Adverse Event Analysis in Bioequivalence Clinical Trials

• Main Authors: A. B. Verveda (Author), V. B. Vasilyuk (Author), G. I. Syraeva (Author), M. V. Faraponova (Author)
• Formato: Livro
• Publicado em: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2024-04-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: 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...