The role of drug safety guideline is to protect patients from occasional, severe adverse reactions; maximum efforts are directed at initial detection and preclusion of serious events. It is projected here that drug toxicity should be demarcated based not only on dose–response relationship, but also as a function of pharmacology, chemistry, metabolism, and environmental and genetic risk aspects. An effectual process can help us recognize safety signals early and give us the opportunity to develop efficient risk minimization plan initially in the development cycle. This alertness has led many pharmaceutical sponsors to arrange internal systems and structures to effectively carry out safety assessment at all levels. Furthermore, processing tools have appeared that are designed to improve data review and pattern recognition. Keeping patient safety during clinical trials under a check, is a perilous component throughout the drug development life-cycle. Pharmaceutical sponsors should work proactively and collaboratively with all stakeholders to safeguard a systematic approach to safety monitoring.
Key words: toxicology, serious adverse events, clinical trials, safety.