In moving to clinical studies, it is important to determine the most likely measures, models and designs for ensuring the success of a new chemical entity (NCE). We continuously strive to provide tests and study strategies that may be applicable to the clinic.

Examining the signature of an NCE across multiple tests and behavioral domains ensures that positive preclinical efficacy is not confounded by non-specific side effects, and further helps identify relevant clinical measures and populations. This approach can also be used to identify safety margin profiles that can be instrumental in the design of effective clinical trials.

We suggest an approach in which tests across species are used to improve likelihood of success. Each may have advantages and limitations, but the collective knowledge across multiple species differentiates compounds and increases confidence in proceeding from the preclinical proof of concept to clinical stages. Building insight into PK-PD relationships across species may also help to derisk extrapolation to the clinic.