Risk Management in Preclinical Trials as Part of an Overall Integrated Quality Management System

• Hoofdauteurs: M. A. Zaytseva (Auteur), M. B. Ivanov (Auteur), A. B. Verveda (Auteur), L. V. Lyanginen (Auteur)
• Formaat: Boek
• Gepubliceerd in: Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products», 2020-03-01T00:00:00Z.
• Onderwerpen: article
• Online toegang: Connect to this object online.

The implementation of a complex risk-oriented approach at all stages of drug development, including the preclinical research stage, is essential for ensuring drug safety, quality and effi cacy. The aim of the study was to justify the benefits of introducing risk management into the integrated quality...