Safety Assessment
General Toxicology Capabilities
– Full range of classical general toxicology studies
– Acute, single administration, PK, maximum tolerated dose, repeated dose
administration and 2, 4,13, 26 or 52 week duration studies
– Vaccine and immunotoxicity studies
– Daily administration or cyclical dosing
– iv (bolus and infusion), oral, sc, ip, dermal
– A team of Senior Study Directors with an average of 10+ years of experience,
with knowledge of current regulatory guidelines
– Collaborative and interdisciplinary exchange of information, ideas, results and
scientific discussion between departments and sites
– Significant experience with biologicals
– Capacity, capabilities and expertise to provide meaningful and compliant results
within study plan driven and accelerated timelines
– Broad NCE experience
