Davide Di Tonno, Laura Martena, Manuela Taurisano, Caterina Perlin, Anna Chiara Loiacono, Stefano Lagravinese, Santo Marsigliante, Michele Maffia, Susanna Esposito, Gianluca Villa, Giovanni Gori, Leonardo Bray, Alessandro Distante, Alessandro Miani, Prisco Piscitelli, Alberto Argentiero
Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes. In the UK and Italy, particular attention should be paid to the Medicines & Healthcare Products Regulatory Agency (MHRA) phase I accreditation scheme and the specific rules set by the Italian Drug Authority through the AIFA Determination no...
March 13, 2024: Epidemiologia (Basel)