Post–IND Services

Ricerca provides a variety of laboratory services and in vivo studies that support clinical development. They are all conducted in accordance with GLP, and are tailored for the needs of each specific development effort. Our scientific and advisory staff can assist in designing programs that are comprehensive, efficient, and cost effective.

ADME

These studies assess the distribution of radiolabeled drug in tissues over time, determine the routes and rates of excretion, and examine the overall recovery of radioactivity following dose administration. Selected excreta, plasma and tissue samples are used to produce metabolite profiles for the toxicology species and these profiles are compared to those obtained in humans. Commonly, 14C labeled drug is used for ADME studies, but Ricerca has experience and expertise to employ other isotopes (3H, 35S) as well.
  • Excretion mass balance in rats, dogs and monkeys
  • Tissue distribution

Chronic Toxicology

Chronic toxicity studies of 6 months in rodents and 9 months in non–rodents are generally performed when a candidate is showing strong clinical potential. Study conduct is similar to toxicity studies of shorter duration and dose selection is critical to support intended clinical use. Ricerca’s teams provide dependable execution of toxicity studies and our scientific staff can partner for selection of dosages and comprehensive study designs.

Carcinogenicity

Ricerca is experienced in conducting lifetime oncogenicity and carcinogenicity of up to 2 years duration in rats and mice. Leveraging technical expertise, electronic data collection, analytical support, and full pathology services, our team provides enthusiasm and detailed oversight throughout the study duration.