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.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
Talphera Cuts NEPHRO CRRT Study Size, Secures $14.8 Million Private Placement
April 1st 2025The trial size adjustment, along with protocol modifications and the addition of higher-enrollment sites, is expected to facilitate completion of the NEPHRO CRRT study of Niyad in patients undergoing renal replacement therapy by the end of 2025.
