Evaluation of DILI Predictive Hypotheses in Early Drug Development.

The most successful approaches to predict DILI potential all include a measure of dose, yet there is a quantifiable uncertainty associated with the predicted dose early in drug development. Here, we compare the possibility of predicting DILI potential using the BDDCS classification versus previously published methods and note that many hypothesized predictive DILI metrics do no better than just avoiding BDDCS Class 2 drugs.