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Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more

For decades, in vivo models have been the standard in preclinical testing before a drug moves to first-in-human (FIH) trials. But a recent evolution in regulatory expectations has accelerated a steady shift away from in vivo testing, in favor of New Approach Methodologies (NAMs). read more