All About Toxicology
Building Strong Foundations in Toxicology ToxMaster has released a new free, DABT-oriented quiz titled “General Principles of Toxicology – Part 1”, designed to strengthen foundational understanding of toxicological concepts essential for students and professionals alike. This quiz is based on Chapter 2: General Principles of Toxicology from Casarett & Doull’s The Basic Science of Poisons,…
Genetic toxicology remains one of the most critical and consequential endpoints in the safety evaluation of pharmaceuticals. Recent scientific discussions within the toxicology community have highlighted how genetic toxicology assessments are strategically applied across early screening, regulatory development, and emerging impurity-related challenges. These discussions underscore evolving regulatory expectations, advances in testing strategies, and practical pathways…
The European Union has formally adopted Regulation (EU) 2025/2509 on the safety of toys, replacing the long-standing Toy Safety Directive 2009/48/EC. The Regulation was adopted on 26 November 2025 and published in the Official Journal of the European Union, with the objective of strengthening child protection while ensuring harmonised enforcement across Member States . Unlike…
New Approach Methodologies (NAMs) are steadily influencing modern toxicology and chemical risk evaluation, offering alternatives that reduce reliance on traditional testing strategies. While enthusiasm around these tools is increasing, researchers caution that premature declarations of success may create unrealistic expectations about their current capabilities. Scientific observers note that when bold claims are made before the…
For decades, LDL cholesterol (LDL-C) was considered the primary marker for assessing heart disease risk. But emerging scientific insights show that relying on LDL-C alone paints only part of the picture, sometimes a misleading one. Today, cardiologists and researchers emphasize that heart disease is better understood through particle numbers rather than just cholesterol content. A…
A new review published in Current Environmental Health Reports reports that artificial intelligence (AI) is driving one of the most significant transformations in modern toxicology. According to researchers Thomas Hartung and Thomas Luechtefeld, AI is now central to interpreting complex biological data, predicting chemical hazards, and improving the human relevance of safety assessments, often outperforming…
The European Chemicals Agency (ECHA) has released updated guidance on the use of OECD Test Guidelines (OECD TG 442 C–E) and Defined Approaches (OECD GL 497) for Skin Sensitisation, further strengthening the transition toward non-animal testing under REACH. The updated guidance clarifies when in chemico, in vitro, and in silico approaches can be used to…
December 2, 2025 — The U.S. Food and Drug Administration (FDA) has released new draft guidance aimed at significantly reducing, and in some cases eliminating, six-month non-human primate (NHP) toxicity studies for certain monoclonal antibody (mAb) products. The move marks a major step in the agency’s ongoing efforts to modernize nonclinical drug evaluation and transition…
The Academy of Toxicological Sciences (ACT) has announced an upcoming webinar titled “Overview of the Draft ICH Q3E Guideline”, scheduled for December 10, 2025. The session will focus on the newly released Step 2b ICH Q3E Draft Guideline for Extractables and Leachables, which entered public consultation on August 1, 2025 and will remain open through…
The U.S. Food and Drug Administration (FDA) has released the draft guidance “Q3E Guideline for Extractables and Leachables,” now open for public and stakeholder comments until 30 January 2026. This draft guideline introduces a comprehensive, globally aligned framework for assessing extractables and leachables (E&Ls) in pharmaceutical products, biologics, and combination medical products. Developed in collaboration…