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Clinical drug attrition rates have remained high at 80-91% over the past six decades, with approximately 77% of failures due to biological factors, demonstrating the limited predictive value of prevailing animal-based preclinical models and the need for human-relevant New Approach Methodologies. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

Need for NAMs: A systematic evidence synthesis revealing over half a century of drug development failure

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