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Nature publishes article on predicting adverse effects to new drugs

ToxStrategies Information Specialist Ms. Seneca Fitch is among a group of scientists from the regulatory community, academia, the pharmaceutical industry, and consulting who have published an article in Scientific Reports (an open-access publication of the journal Nature). The paper investigates why some new drugs, having survived the rigorous process of animal and human testing necessary to bring them to market, end up causing unexpected, and sometimes severe, adverse drug reactions in the wider patient population (killing more than 10,000 patients annually in the United States). The authors point out that a battery of new tests and techniques have emerged in the last few decades (referred to as new approach methods [NAMs]) to study the mechanisms of toxicity of chemicals and identify endpoints of concern. Pursuing three separate evidence streams for specific drugs associated with drug-induced liver injury, they propose a “paired-compound approach” to comparing various tests, to reach a systematic, transparent, and evidence-based approach to drug development.