Preclinical Safety: From In Vitro Assays to Human Dose Predictions

week 1

• pharmacology & toxicology

• preclinical safety timeline

• tragedies in drug safety

• in vitro safety assays

• risks from hERG channel inhibition

week 2

• on-target toxicity

• in vivo toxicology studies

• drug-drug interactions

• intra-family target selectivity

• drug purity and safety

week 3

• efficacy vs. safety risks

• maximum recommended starting dose

• safety in oncology drugs

• preclinical safety concurrent with clinical trials

• post-approval surveillance