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Elsevier Study Probes How Animal Studies Predict Human Safety
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.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
