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One of the biggest issues facing the pharmaceutical business is the high attrition rate in medication development, which is mostly caused by unexpected toxicity and lack of efficacy in people. Animal research and two-dimensional cell cultures are the mainstays of conventional preclinical evaluation, and both have established limitations in terms of forecasting human reactions. Organ-on-a-chip (OoC) technology, also known as microphysiological systems (MPS), replicates important structural and functional characteristics of human organs in vitro under regulated fluid flow and mechanical inputs by combining microfluidics, tissue engineering, and human-derived cells. The purpose of OoC platforms, their design concepts, and the primary organ models (liver, kidney, lung, gut, heart, brain, and bone marrow) utilized for toxicity assessment are all summarized in this article. The current regulatory environment, multi-organ and body-on-a-chip systems for pharmacokinetic and toxicokinetic research, and the technological and standardization issues that continue to impede widespread implementation are then covered. OoC models can identify human-relevant toxicities that animal models overlook, according to available data. However, before they can take the place of animal testing in regulatory decision-making, they must undergo more extensive validation, repeatability, and qualification for a specific context of usage.
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Ambade et al. (2026) studied this question.
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