Therapeutic index, exposure margins, FIH dosing, QTc analysis, exposure-response
Calculate Therapeutic Index (TD50/ED50) and Certain Safety Factor (TD1/ED99) for drug safety margins
Calculate AUC and Cmax exposure margins from animal NOAEL to human therapeutic dose per ICH M3/S9
Calculate maximum recommended starting dose (MRSD) for first-in-human trials using FDA BSA or allometric methods
Perform concentration-QTc analysis with linear regression, 90% CI, and ICH E14 threshold assessment
Fit logistic regression to binary exposure-response data with EC50, odds ratio, and predicted probabilities