Toxicity Biomarkers In Vitro

The driving force for better clinical biomarkers of potential adverse events is to monitor patient safety, and many such biomarkers will be discovered and developed within the context of human medicine. However, from a nonclinical perspective the discovery and development of toxicological biomarkers facilitates the translation to the clinic of knowledge that will avoid or minimize the risk of occurrence of a potential unwanted outcome identified in animal studies. Thus, it is key to identify preclinical biomarkers of the adverse response of animals to potential new drugs and to evaluate fully their relevance and applicability to humans.

Potential biomarkers can be identified in vitro, and their translation to in vivo, either in animal or humans, evaluated at a later date. This concept is developed later in this review with specific examples and case histories. One argument against this approach is that findings in animals in vivo or in animal-derived tissue in vitro may not be relevant for human safety; however, the job of the clinician is to manage the best possible therapy while minimizing the risk of adverse reactions. Thus, such data would form part of an integrated assessment of safety and efficacy that can inform preclinical and clinical decisions.

Clinically useful biomarkers of toxicity can be derived from appropriately designed preclinical experiments, and such biomarkers can significantly assist safe progression into the clinic with an approach design to minimize patient risk. These biomarkers can be derived from in vitro or in vivo mode-of-action studies in preclinical species then translated to potential clinical use or, as we present here, could already be established in clinical practice. This transla-tional science approach requires close collaboration between the clinical and the preclinical scientists.

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