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Background Research and drug development industries have multiphase drug screening procedures, which can be debated. As a result, harmful products may still reach for public health service delivery due to vulnerabilities in the process. Main body A wide range of test compounds have delayed manifestation of undesired effect on the study subject, with the time to undesired effects after acute exposure being weeks and months. Acute toxicology in a preclinical trial also has limited clinical value as its lethal dose is the endpoint for a conclusion, and death sometimes occurs after a scheduled period of acute toxicology. Countless resources are wasted, and numerous new drugs are introduced into the pharmaceutical market with assumed safety analysis every year due to vulnerable multi-procedures in preclinical trials. The principal use of collected data from a preclinical trial is to support regulatory categorization and harmful labelling decisions. However, the data can also be used to derive safe use threshold levels, which may lead to the use of unsafe material. The criteria for classification and labelling also differ among countries, sometimes among authorities within the same country. The fundamental concept of toxicology states that ‘all chemical substances are potential poisons depending on the amount and duration of exposure. However, the toxic property of a test compound cannot be created or eliminated by simply the amount administered to study animals. Conclusion All xenobiotics are poisons at any amount with different severity that can be calculated using biological parameters.
Drug-induced cardiotoxicity is one of the predominant reasons for drug attrition and withdrawals. This is of critical concern when potentially cardiotoxic drugs are administered to individuals with inherited arrhythmogenic cardiac diseases or with metabolic diseases such as obesity and diabetes, which are key risk factors for cardiovascular diseases. Pathophysiological alteration prevalent under such conditions can alter or exacerbate cardiotoxic responses. The growing incidence of obesity, diabetes and metabolic syndrome subject a significant percentage of the population to drug treatments, thereby augmenting their risk for drug-induced cardiovascular toxicity. Hence, screening for drug-induced cardiotoxicity early in the preclinical stages of drug development, by using appropriate human disease models, can be effective in ensuring safety in clinical trials and preventing late stage and post-marketing drug withdrawals owing to cardiotoxicity. The advent of human pluripotent stem cells (hPSC) and induced pluripotent stem cell (iPSC)-derived cardiomyocytes are revolutionizing safety/toxicity screening in human cells by providing relevant human-specific, renewable model systems to explore human drug toxicity. The ability to generate patient-specific iPSCs that can model cardiac diseases, now offers a valuable option that can further improve drug safety assessments and enable a more accurate prediction of toxicity that occurs in the representative population that are prescribed the drugs. Use of appropriate disease models will not only provide cost savings by decreasing potential drug attrition and withdrawals, seen with many drugs, but will also be a promising option to advance precision medicine