Starting with the finish line in mind, by including safety and tolerability endpoints in our efficacy and PK studies across multiple species, we are able to identify potential risks and liabilities in NCEs early, thereby avoiding unnecessary delays further down course.

Models

  • A Functional observation test battery for either the rat or mouse adapted from the Irwin (1968) test screen, and incorporating additional objective measures of motor and autonomic function.

  • Unique adverse effects may be suspected based on the pharmacological property or observations made during the drug characterization process. Additional concerns may arise during clinical trials. In such cases, follow-up studies are recommended (ICH S7A). We can provide the following supplemental services:

    1. Tests for dependence and abuse liability;
    2. Tests for cognitive liability; and
    3. Tests for pro-convulsant liability.

  • Animals can be chronically treated with an NCE under staggered designs such that 2nd/3rd level dosing can be determined by the effect at first dose. Daily observation, blood chemistry and cell counts are included. Additional options include: major organ histopathology; plasma sampling for toxicokinetic profiling; CSF sampling (in the dog); and incorporation of a functional CNS test battery into the study design. Our emphasis is on flexible designs to maximize the value of information to the customer to guide subsequent efficacy and GLP toxicology studies.

  • Frequently, drugs are administered in combination with another therapy. We offer the capability to test for potentially deleterious drug-drug interactions, both at the behavioural and pharmacokinetics level.

  • Animals can be treated with an NCE by either iv, sc, ip or oral routes of administration and plasma samples taken at multiple timepoints. Additional tissue samples, e.g. csf (rat) can be taken to determine CNS penetration of NCE. These can also be coordinated with efficacy studies to support PK-PD determinations.