STP position paper: interpreting the significance of increased alveolar macrophages in rodents following inhalation of pharmaceutical materials.
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.
['Nikula|Kristen J|KJ|', 'McCartney|Jeffrey E|JE|', 'McGovern|Timothy|T|', 'Miller|Glen K|GK|', 'Odin|Marielle|M|', 'Pino|Michael V|MV|', 'Reed|Matthew D|MD|']
D000818:Animals D035843:Biomedical Research D048429:Cell Size D019570:Inhalation Exposure D016676:Macrophages, Alveolar D051381:Rats D018570:Risk Assessment D012958:Societies, Scientific D018675:Toxicity Tests
inhalation risk assessment drug development lung preclinical safety assessment pulmonary. risk management