Elsevier Study Probes How Animal Studies Predict Human Safety

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Pharmaceutical Executive

Elsevier, global information analytics business, conducted a big data analysis evaluating the ability of animal studies to predict human safety. The statistical study was carried out with the Investigational Toxicology department at Bayer AG’s Pharmaceuticals division and examined the consistency between preclinical animal testing and observations made in human clinical trials.

The study analyzed 1,637,449 adverse events reported for both humans and the five most commonly used animals in FDA and EMA regulatory documents, for 3,290 approved drugs and formulations. The results shown that some animal tests are more predictive of human response than others, depending on the species and symptom being reported.


The full study (‘A Big Data Approach to the Concordance of the Toxicity of Pharmaceuticals in Animals and Humans’) will be published in the Journal of Regulatory Toxicology and Pharmacology; the article has also been made available through open access.