Pathology

Pathologists provide a foundational role in exploring the causes and effects of a disease using samples of body tissues or fluids. In toxicologic pathology this foundational role extends to the assessment of the safety of a drug, compound, device or vaccine. The pathologist identifies, characterizes and manages risk versus benefit. 

• Immunohistochemistry (IHC) 
• Electron Microscopy (TEM)
• Tissue Cross Reactivity (TCR)
• In Situ Hybridization (ISH)
• Tissue and Target Profiling
• Digital Pathology
• Exploratory Clinical Biomarkers

• Analytic evaluations conducted on samples collected from humans and necropsied animals
• Tissue examination
• Nonclinical studies (GLP & non-GLP); only evaluation that will not be repeated in clinical studies
• Single endpoint

• Analytic evaluations conducted on samples collected from living humans and animals
• Fluid examination 
• Nonclinical or clinical study (see clinical testing services)
• Multiple collections possible during a study (depending on species)

• LRRK2 inhibitors induce reversible changes in nonhuman primate lungs without measurable pulmonary deficits. (NCBI)
• Scientific and Regulatory Policy Committee Points to Consider*: Approaches to the Conduct and Interpretation of Vaccine Safety Studies for Clinical and Anatomic Pathologists (NCBI)
• Atlas of Normal Microanatomy, Procedural and Processing Artifacts, Common Background Findings, and Neurotoxic Lesions in the Peripheral Nervous System of Laboratory Animals (NCBI)