Antonio Anax Falcão de Oliveira,Octavio Presgrave,Cristiane Caldeira da Silva et al.
Antonio Anax Falcão de Oliveira et al.
Brazil has advanced its chemical regulatory framework with the enactment of Law No. 15,022/2024, which establishes the National Inventory of Chemical Substances, aligning the country with international chemical management systems. The law c...
Corrigendum to "Global regulatory considerations and practice for tumorigenicity evaluation of cell-based therapy" [2025 Feb;156:105769] [0.03%]
Dehu Dou,Jing Lu,Jinhui Dou et al.
Dehu Dou et al.
Provocation of occupational asthma by non-specific irritation and its relevance for the classification of chemicals as respiratory allergens: a case study of methyl methacrylate [0.03%]
Mark A Pemberton,Stuart Hindle,Ian Kimber
Mark A Pemberton
Allergic sensitisation of the respiratory tract by chemicals, commonly associated with asthma, is an important adverse health effect. However, the accurate identification of true chemical respiratory allergens remains problematic. In the ab...
Integrating new habits and practices data and homecare products into the Creme RIFM aggregate exposure model [0.03%]
Isabelle Lee,Ben Smith,Brendan Ring et al.
Isabelle Lee et al.
The Research Institute for Fragrance Materials (RIFM) and Creme Global, in collaboration with fragrance and consumer products industries, have developed an aggregate exposure model for fragrance ingredients in cosmetics, personal care, and ...
Contamination and adulteration of food supplements: Risk perception and regulatory awareness in recreational athletes [0.03%]
Sofia Lopes,Madalena Cunha,Ana S Fernandes et al.
Sofia Lopes et al.
There is growing concern about the toxicological risks resulting from the contamination and adulteration of food supplements (FS), which may pose significant health hazards. Heavy metals, undeclared pharmaceuticals, stimulants, and other co...
Jeong-Woo Lee,Heejin Park,Tae-Yang Jung et al.
Jeong-Woo Lee et al.
Bisphenol F (BPF), developed as a safer alternative chemical to bisphenol A (BPA), is increasingly used in epoxy resin, coating, adhesive, and plastic production. However, despite its growing use, recent research indicates that it may be un...
Risk-based strategy for evaluating and controlling residual protein impurities in enzymatically synthesized calcium gluconate: Bridging analytical detection to safety assessment [0.03%]
基于风险的策略评估和控制酶法合成葡萄糖酸钙中的残留蛋白杂质：从分析检测到安全评估
Zhuyu Jin,Qiaoqiao Huang,Xiao Sun et al.
Zhuyu Jin et al.
Regulatory bodies (e.g., FDA, NMPA, EDQM) mandate control of residual protein impurities in enzymatically produced pharmaceuticals, yet a standardized, risk-informed methodology for their safety assessment is lacking. This study addresses t...
Assessment of chronic toxicity study designs and development of a weight-of-evidence-based decision-making model for biopharmaceuticals: A survey of Japanese pharmaceutical companies [0.03%]
日本药企对生物制剂慢性毒性试验方案的评估及权重证据法决策模型的发展：调查研究
Yui Suzuki,Tetsuo Aida,Bunichiro Ogawa et al.
Yui Suzuki et al.
We surveyed 17 pharmaceutical companies in Japan, covering 121 biopharmaceutical projects-including mAbs, bispecific antibodies, Fc-fusion proteins, and other protein therapeutics, to characterize chronic toxicity study designs and rational...
Human vs. cells vs. machine: A comparative analysis of toxicological points of departure derived from quantitative read-across (qRAx), in vitro data, and In silico predictions [0.03%]
人 vs. 细胞 vs. 机器：基于定量跨模型（qRAx）、体外数据和计算机模拟预测的毒理学研究点的比较分析
Weihsueh A Chiu,Hannah M Roe,Ivan Rusyn
Weihsueh A Chiu
Read-across is an expert-driven new approach methodology (NAM) used to fill gaps in chemical toxicity data. While qualitative read-across is widely used, quantitative read-across (qRAx) for deriving points of departure (PODs) has received l...
ExSERA: The explainable machine learning model for skin sensitization risk assessment [0.03%]
用于皮肤敏化风险评估的可解释机器学习模型ExSERA：
Kaori Ambe,Kei Kinoshita,Juri Tokunaga et al.
Kaori Ambe et al.
The development of new approach methodologies using machine learning offers promising alternatives to animal testing for toxicity assessment. However, to be suitable for regulatory use, machine learning models must ensure transparency and i...