The shifts in drug testing methodologies come as a result of past failures, such as the TGN1412 trial, where a drug that showed no toxicity in cynomolgus monkeys caused severe immune reactions in healthy human participants. This incident has propelled the FDA to explore and encourage the use of alternative testing methods, such as in vitro cellular assays, organoids, and organ-on-a-chip technology, to better predict human responses and increase the safety of biologic drugs without relying solely on animal models.
The limitations of animal models for certain immune-activating monoclonal antibodies have been highlighted, prompting the FDA to shift toward alternative testing methods that better reflect human responses.
The case of TGN1412, with its severe immune reaction in humans despite safe trials in monkeys, underscores the critical need for improved preclinical research methodologies.
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