Toxicology & Pharmacology

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
• Neuro Toxicity 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, the primary objective is to move quickly to human administration to see if it is going to work. But first the drug candidate must be deemed safe. Determination of safety for humans is done by evaluating toxicity in animals and by in vitro interspecies comparisons. Often though, the client doesn't know how to design the protocol. Here's an example. A midsize biopharma company brought its drug candidate to Ricerca for the acute toxicity study needed to file an IND and support the Phase I clinical protocol. Ricerca helped the client choose the study parameters (dose rate, animal species, route of administration, animal population distribution) and wrote the protocol. The client got not only a well-executed study and the requisite data package but the consulting advice they needed. Additionally, they will have the benefit of Ricerca's familiarity and understanding of the compound when we help plan the toxicokinetic study.