Preclinical Safety: From In Vitro Assays to Human Dose Predictions

Drugs are approved based on their “safety and efficacy”. Determining the safety of a drug occurs through studies that are largely completely separate from efficacy studies. The safety studies fall under the umbrella of preclinical safety. While a drug’s therapeutic benefit is typically narrow and well-defined, the potential safety risks of a compound can be very broad. Preclinical studies therefore search broadly in order to reveal any possible safety issues in a compound. Safety studies ultimately determine dosing limits for clinical trials as well as the final approved drug product.