STP position paper: interpreting the significance of increased alveolar macrophages in rodents following inhalation of pharmaceutical materials.
Toxicol Pathol
; 42(3): 472-86, 2014.
Article
em En
| MEDLINE
| ID: mdl-24178583
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Macrófagos Alveolares
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Testes de Toxicidade
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Exposição por Inalação
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Pesquisa Biomédica
Tipo de estudo:
Etiology_studies
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Risk_factors_studies
Limite:
Animals
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article