Drug safety assessment is the systematic evaluation of the potential harms of a medicinal product across its life cycle, aimed at characterizing its safety profile and ensuring that benefits outweigh risks for intended use. It integrates preclinical toxicology, clinical-trial safety monitoring, and post-marketing su…
Drug safety assessment is the systematic evaluation of the potential harms of a medicinal product across its life cycle, aimed at characterizing its safety profile and ensuring that benefits outweigh risks for intended use. It integrates preclinical toxicology, clinical-trial safety monitoring, and post-marketing surveillance, drawing on pharmacology, toxicology, and pharmacovigilance to detect, quantify, and manage adverse effects. Preclinical evaluation includes acute and subacute toxicity studies in animal models, exemplified by toxicity assessment of plant-derived extracts, and increasingly computational and systems-biology approaches that predict toxicity from biological data. Safety considerations extend to the discovery and development of therapeutic agents, where mechanisms such as immune responses inform the design of safer drugs, and to broader reviews of toxicology and drug-safety issues across agent classes. Real-world safety encompasses appropriate use and storage of medicines, since self-medication and improper drug handling create avoidable hazards, and the detection of adulterants in products such as dietary supplements, which can introduce undeclared and dangerous active substances. Analytical chemistry supports these efforts through identification and quantification of contaminants and active ingredients. Risk management combines hazard identification, surveillance, and regulatory action to minimize harm. As a scholarly topic, drug safety assessment integrates toxicology, pharmacovigilance, analytical science, and clinical research to evaluate and control the risks of medicines and related products, safeguarding patients before, during, and after market availability.
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The 7 articles above have been cited 70 times in the scholarly literature. Citation data via OpenAlex and Crossref, updated Jun 2026.
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