The harmful effects of a drug.
Toxicity is one of the most common reasons for a drug to fail during clinical development. Toxicology studies traditionally focused on the effects of a drug in animal models, but increasingly in vitro cellular and biochemical approaches are also being used. To a degree, potential toxicity issues can now also be predicted on the basis of chemical structures (‘in silico toxicology’).
Antimicrobial Safety and Tolerability: Differences and Dilemmas (Clinical Infectious Diseases, 2001)
Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (FDA, 2010)
Scientific guidelines on non clinical toxicolology (EMA, 2020)
Safety Pharmacology in Drug Discovery and Development (Handbook of Experimental Pharmacology, 2015)
REVIVE webinar: ‘Making Safety a Part of Drug Design’ by Claire Sadler (GARDP, 2018)