Core Viewpoint - The FDA has initiated a significant project aimed at validating non-animal methods for predicting drug-induced liver injury, with completion expected in Q1 2026 [1][3]. Group 1: FDA's Initiative - The FDA is collaborating with multiple organizations, including YaoSu Technology, to implement a cross-platform drug validation project using organ-on-a-chip technology [3][4]. - The project aims to enhance the accuracy and efficiency of toxicity assessments, reducing reliance on animal testing [4][6]. - The FDA's recent policy updates encourage the use of organ chips and AI modeling in early drug development stages, signaling a shift in research funding priorities [3][10]. Group 2: Cost and Time Efficiency - Utilizing organ-on-a-chip technology can significantly reduce the time required for toxicity testing, with some tests potentially completed in two weeks compared to several months for traditional animal testing [5][6]. - The cost of animal testing is substantial, with a mouse costing around 100 yuan and a monkey potentially costing up to 100,000 yuan, making non-animal methods financially attractive [4][6]. Group 3: Accuracy of Testing Methods - Current animal models have a liver injury prediction accuracy of only 50% to 65%, which is marginally better than random chance [6][9]. - Organ-on-a-chip technology could improve prediction accuracy to between 80% and 90%, leading to significant cost savings in drug development [6][9]. Group 4: Challenges and Future Directions - There are still significant technical and regulatory hurdles to fully replace animal testing, with a complete transition unlikely within the next decade [8][10]. - The FDA's goal is not to eliminate animal testing entirely but to shift the focus towards in vitro models, using animals only when necessary [9][11]. - The development of multi-organ chips that can simulate human physiology remains a long-term objective, requiring further research and standardization [9][10].
猴子终于不必再为人类试毒？ | 海斌访谈