Ricerca toxicity and PK studies provide a full safety assessment

Ricerca can demonstrate the safety of your drug candidate and provide the data required to support your IND. Typically, we perform 14- or 28-day toxicity studies in two or more animal species. A variety of dosing regimens is supported. Extended duration studies to support chronic dosing regimens are also performed.

• Toxicokinetic/Pharmacokinetic studies 
• Single dose toxicity studies
• Repeated dose toxicity studies
• Local tolerance studies
• Carcinogenicity studies
• Neurotoxicity studies
• Acute toxicity studies
• Animal efficacy models

We offer guidance in preparation of your animal study protocols balancing timing, cost and risk factors to ensure that you will have appropriate data to support Phase II and III clinical studies as well as the complete data package needed for the first human administration of new candidate drugs. We can also help you prepare your IND submission. Strong on-site bioanalytical support insures that you'll have good toxicokinetic and dose solution stability data.

Once a compound is selected for drug development it must be deemed safe. Determination of safety for humans is done by evaluating toxicity in animals and by in vitro interspecies comparisons. Ricerca helps clients choose the study parameters (dose rate, animal species, route of administration, animal population distribution) and writes the protocol. Our significant experience in conducting the studies and developing the requisite data package and reports for IND submission can help insure the success of potential candidates.