The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies

The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies

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 mitigat...

Full description

Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: MDPI AG 2024-03-01
Series:Epidemiologia
Subjects:
Phase 1 Clinical Trials
risk management
European Regulation
new drug development
UK
Italy
Online Access:https://www.mdpi.com/2673-3986/5/1/9

Internet

https://www.mdpi.com/2673-3986/5/1/9

Similar Items