Model-Informed Drug Development: A Risk Firms, Regulators Need To Embrace

Increased use of modeling in drug development could better inform candidate selection, optimize dose selection, and support novel endpoints, labeling and postmarketing safety.

However, regulators, sponsors and the clinical community will have to take the risk of stepping away from the well-trodden path of drug development if they are going to embrace modeling and its efficiencies, stakeholders said at a Feb