TOXICOLOGY AS A FOUNDATION OF MODERN DRUG SAFETY EVALUATION

Abstract

Modern drug development relies fundamentally on toxicology to ensure that newly developed medicinal products do not pose unacceptable risks to human health. As pharmaceutical compounds become increasingly complex, including synthetic small molecules, biological products, and advanced delivery systems, the need for thorough toxicological evaluation has intensified. Toxicology provides scientific methodologies to identify hazardous properties, characterize dose- and time-dependent toxic effects, and elucidate mechanisms underlying adverse reactions. Furthermore, toxicological studies support regulatory decision-making and contribute to risk–benefit assessment throughout the drug lifecycle. This article discusses toxicology as a foundational discipline in drug safety evaluation, emphasizing mechanisms of toxicity, toxicokinetic assessment, risk management strategies, and modern approaches that enhance the prediction and prevention of drug-induced harm.