TOXICOLOGY AND BIOMARKERS
Biomarkers, which are reliable, applicable, and reproducible are important tools to understand and develop new therapeutic treatments for the promotion of human health and the prevention of toxic side effects. McArthur and Associates provide support and define toxicological and biomarker activities through our resident expertise in toxicology and biostatistics.
- Preclinical development plans including safety pharmacology and preparation of clinical Phase 1 studies.
- Compliance with EMA, ICH, or National safety-based guidance on the evaluation of drug safety.
- Identification of and interaction with GLP-accredited CROs.
- Definition of regulatory strategies.