A Mechanistic, Model‐Based Approach to Safety Assessment in Clinical Development
A Mechanistic, Model‐Based Approach to Safety Assessment in Clinical Development
Assessing the safety of pharmacotherapies is a primary goal of clinical trials in drug development. The low frequency of relevant side effects, however, often poses a significant challenge for risk assessment. Methodologies allowing robust extrapolation of safety statistics based on preclinical data and information from clinical trials with limited numbers …