title: STP position paper: interpreting the significance of increased alveolar macrophages in rodents following inhalation of pharmaceutical materials.
abstract: 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.
authors.affiliation: 1Seventh Wave Laboratories LLC, Chesterfield, Missouri, USA.
authors.forename: Kristen J
authors.initials: KJ
authors.lastname: Nikula
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: McCartney
authors.forename: Timothy
authors.initials: T
authors.lastname: McGovern
authors.forename: Glen K
authors.initials: GK
authors.lastname: Miller
authors.forename: Marielle
authors.initials: M
authors.lastname: Odin
authors.forename: Michael V
authors.initials: MV
authors.lastname: Pino
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Reed
mesh_terms: D000818:Animals; D035843:Biomedical Research / Q000379:methods / Q000592:standards; D048429:Cell Size; D019570:Inhalation Exposure; D016676:Macrophages, Alveolar / Q000166:cytology / Q000187:drug effects; D051381:Rats; D018570:Risk Assessment; D012958:Societies, Scientific; D018675:Toxicity Tests / Q000379:methods / Q000592:standards
keywords: drug development; inhalation; lung; preclinical safety assessment; pulmonary.; risk assessment; risk management