Nikula Kristen J, McCartney Jeffrey E, McGovern Timothy, Miller Glen K, Odin Marielle, Pino Michael V, Reed Matthew D
1Seventh Wave Laboratories LLC, Chesterfield, Missouri, USA.
Toxicol Pathol. 2014;42(3):472-86. doi: 10.1177/0192623313507003. Epub 2013 Oct 31.
The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology (STP) appointed a working group to address risk assessment for increases in alveolar macrophages following inhalation of pharmaceutical materials. This position paper provides recommendations for inhalation study-specific terminology and interpretation based on literature and information from marketed inhaled drugs. Based on a weight-of-the-evidence approach, and with appropriate consideration of the physical and pharmacological characteristics of the compound, uncomplicated increases in the size or number of alveolar macrophages in nonclinical species are interpreted as nonadverse.
毒理病理学会（STP）的科学与监管政策委员会任命了一个工作组，以解决吸入药物材料后肺泡巨噬细胞增加的风险评估问题。本立场文件根据已上市吸入药物的文献和信息，提供了吸入研究特定术语和解释的建议。基于证据权重方法，并适当考虑化合物的物理和药理特性，非临床物种中肺泡巨噬细胞大小或数量的单纯增加被解释为非有害。
