Therapeutic index12/11/2023 ![]() ![]() In modern settings, more sophisticated toxicity endpoints are used.įor animals in pre-clinical trials, Therapeutic Index = L D 50 E D 50 įor many drugs, severe toxicities in humans occur at sublethal doses, which limit their maximum dose. In the early days of pharmaceutical toxicology, TI was frequently determined in animals as lethal dose of a drug for 50% of the population ( LD 50) divided by the minimum effective dose for 50% of the population ( ED 50). In contrast, in a drug development setting TI is calculated based on plasma exposure levels. efficacious dose in 50% of subjects, ED 50). ![]() ![]() toxic dose in 50% of subjects, TD 50) to the dose that leads to the desired pharmacological effect (e.g. Quantitative measurement of the relative safety of a drugĬlassically, in clinical indication settings for an approved drug, TI refers to the ratio of the dose of drug that causes adverse effects at an incidence/severity not compatible with the targeted indication (e.g. ![]()
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