Pharmaron provides a wide array of routine and specialized toxicologic pathology services to help our partners determine the safety and efficacy, and investigate the potential mechanisms of test articles by which changes are induced. Pharmaron’s pathology team performs pathologic assessments and provides interpretations that meet the requirements of multi-GLP compliance of US FDA, OECD and NMPA.
Pharmaron’s contracted US Board Certified Veterinary pathologists and China board-certified pathologists provide thorough interpretation of pathology data and comprehensive report preparation that includes data acquired by using FDA Part 11 compliant pathology data acquisition systems of Provantis.
- Support preclinical research to fast estimate the potential toxicity of test article
- Provide clinical pathology testing of clinical chemistry, hematology, coagulation, and urinalysis including urine sediment examination, as well as blood platelet aggregation assay with advanced validated instruments
- Clinical pathology data is transferred directly into Provantis
- Collect protocol-specified animal tissues in nonclinical toxicology studies
- Consult with vet pathologist to identify any gross lesions
- Collect organ weight and gross lesions in Provantis
- Tissues collected at necropsy and preserved in adequate medium that are trimmed, dehydrated, embedded in paraffin, sectioned and mounted on glass slides for staining
- Special stains conducted for pathologist to arrive at the most accurate diagnosis when necessary
- Board-certified veterinary pathologists perform pathology evaluations for FDA and/or China NMPA filing studies and prepare integrated pathology report
- Internal peer review is conducted by the in-house chief pathologist
- In-house pathologists conduct microscopic evaluation for Tissue Cross Reactivity studies