Pivotal Toxicology

Ricerca offers pivotal toxicology studies for safety toxicity and toxicity evaluation of candidate compounds. Our toxicological studies are conducted on a variety of animal models. These pivotal studies range from IND-enabling studies to smaller tox studies and provide a basis for identifying hazards and conducting safety assessments that support IND filing and support use in humans. Our IND-enabling toxicology is performed by experienced scientists that can recommend appropriate study parameters and protocol elements, enabling collection of a robust and comprehensive data package for IND submission. Ricerca offers comprehensive expertise to execute your IND study needs with services optimized to meet the most aggressive execution timelines.

General Toxicology

Ricerca’s toxicology business unit provides an array of services for investigational purposes or IND support. Typically, GLP toxicology, GLP toxicity studies, and pivotal toxicity studies are performed in two species for durations of 14 or 28 days, and often include translational biomarkers or investigational endpoints that assist with compound development. Toxicity studies are complemented by safety pharmacology studies, commonly conducted simultaneously to expedite development. All standard dosing regimens and species are supported, including primates, and our GLP tox studies are conducted in strict compliance with GLP regulations. Our GLP toxicology studies have supported hundreds of successful client IND submissions. Please click Request Quote to see how cost effective and time effective we are with your GLP toxicity study, your toxicology study, or your other animal pharmacology and toxicology studies. You will find that Ricerca is outstanding at performing pivotal biosciences research.

Routes of Administration — Rodent Studies

  • Oral gavage, dietary admixture
  • Parenteral (iv, sc, im, infusion)
  • Dermal

Nonrodent Studies (most commonly dog, cat, mini pig, primate)

  • Dermal studies (mini pig)
  • Biomarker identification
  • Experience with biologicals & primates

Routes of Administration — Non–Rodent Studies

  • Oral gavage
  • Intravenous bolus injection
  • Subcutaneous, intramuscular injection
  • Infusion
  • Dermal application
  • Intranasal

Safety Pharmacology

Ricerca’s safety pharmacology studies are designed to identify responses and assist in the prediction of potential adverse effects. Because each candidate’s pharmacology is unique, we work with you to design a customized, detailed portfolio of studies for comprehensive assessment. We routinely conduct stand–alone safety pharmacology studies for small molecule development efforts, and incorporate safety pharmacology endpoints into pivotal toxicology studies for biologicals.
  • Safety pharmacology core battery (ICH S7A)
  • CNS, cardiovascular, respiratory
  • Combined cardiovascular and respiratory assessment in canines and primates
  • Non–invasive / implanted radio telemetry (canine, primate)
  • Functional Observational Battery (FOB) and motor activity
  • Supplemental safety pharmacology studies as may be indicated
    – GI, Renal

Immunotoxicology

We offer methods for assessment of immune system involvement, compromise, or stimulation in various species. We perform dedicated immunotoxicogy studies, as well as incorporating immunotoxicology endpoints into standard pivotal studies.
  • Customized development of ELISA assays with validation
  • Flow cytometry assay development and validation
  • Immunosuppression and immunostimulation analysis
  • Hypersensitivity monitoring
  • Immunopharmacology assessment

Juvenile Toxicology

Ricerca’s juvenile toxicology studies allow quick assessment of drug safety in post–weanling animals, including both rodent and non–rodent species. Standard routes of administration include oral gavage, dietary admixture, subcutaneous, dermal, IM and IV. Study durations range from acute to chronic.