How Do Toxicological Studies Determine Safe Drug Dose Regimes
Toxicological studies in drug development are crucial in characterizing the extent of injury a drug product may have at varying drug doses. Such data help predict potential outcomes and better understand the risk/benefit ratio as to efficacy and safety. Depending on the development phase and individual research needs, sponsors perform both GLP and non-GLP toxicology studies in drug development. Clinical and nonclinical toxicology analysis: Critical for a successful drug product The primary aim of toxicological studies is to characterize the toxicity profile of a drug product and interpret its effects on organ structure and functionality. These assessments include in vivo…