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ABSTRACT:
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.
INTRODUCTION
Emergence of 2019-nCoV (novel Coronavirus) has engrossed global attention recently, and World Heath Organization has acknowledged COVID-19 as a public health emergency of international concern.1Numerous attempts are being made to develop a drug to cure the infection by this novel virus. But to develop a pharmacologically active drug, is a daunting task and the sponsors/ companies who are trying to develop them quickly have to surpass minimum three stages of clinical trials so that market authorization of drug can be achieved which will mainly depend upon the number of adverse effects associated with the intended drug and its risk to benefit ratio which is a lengthy procedure.
Toxicology Principles:
Traditional toxicologists trust on Paracelsus' Principle: "All things are poison and nothing is without poison. Exclusively the dose regulates that a thing is not a poison." This principle of toxicology found in the 15th century is the keystone of today's practice of toxicology. Dose-response relationship is the utmost vital data set from which safety is determined. For drugs, safety is projected based on the therapeutic index, a ratio of the toxic dose to the dose required for efficiency.2 Safety assessment is a fundamental component in all stages of the drug development lifecycle. Before marketing authorization of a...