ICH now requires a dependency study for all new chemical entities (NCEs) that are expected to elicit CNS activity as well as any drug that passes the blood-brain barrier.
“The evaluation of abuse liability should be considered for drugs that are distributed into the brain and produce central nervous system activity, regardless of therapeutic indication. Nonclinical studies should support the design of clinical evaluations of abuse potential, classification/scheduling by regulatory agencies, and drug labeling.” –http://www.emea.europa.eu/pdfs/human/ich/028695endraft.pdf
From our experience these current guidelines would not only apply to NCEs for human use but also for veterinary use where there is potential for the drug to cross the animal’s blood-brain barrier. For example, veterinary anesthetics may be required to be evaluated in dependency studies to assess their potential for human abuse.
Global BDI has expert consultants and laboratory capabilities to perform abuse liability testing. We conduct drug self-administration and drug-discrimination studies in rodents and non-human primates.