Key bioanalytical measurements for antibody-drug conjugate development: PK/PD modelers’ perspective

“When bioanalytical measurements are committed with PK/PD modelers’ perspective in mind, it provides an opportunity to integrate these measurements in a quantitative manner using mathematical PK/PD/toxicodynamic models.” Mathematical modeling can integrate PK, PD and toxicodynamic (TD) data, and can generate and answer key hypotheses. Modeling and simulation techniques can be applied to optimize study design and augment/refine preclinical and clinical experimentation. Additionally, modeling can be instrumental in providing a quantitative framework for preclinical to clinical translation of efficacy and safety. The ultimate quality and confidence in these mathematical models depends upon the data used to build or validate them, highlighting...