Assessment of dependence potential is required for drugs that affect the central nervous system. INA performs highly accurate drug dependence studies based on a wealth of experience and achievements accumulated over many years. Japanese Ministry of Health regulations, and the EMEA/CHMP Guideline on the Non-Clinical Investigation of the Dependence Potential of Medicinal Products (March 23, 2006), are strictly followed to ensure the highest quality data possible.
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Psychological dependence
- Self-administration studies (rats and rhesus monkeys)
It is said that psychological dependence is strongly related to the reinforcing effects of drug taking. The presence or absence of any reinforcing effects and their subsequent effects on the CNS, which develop depending on the amount of drug that is self-administered, are evaluated in rats (intravenous) and rhesus monkeys (intravenous, intragastric). - Drug discrimination studies (rhesus monkeys)
A reinforcing effect is considered to appear based on the perceived effect (internal sense of changes) at the time of drug intake. Thus, it will be investigated whether such sense of changes following administration of the test article (discriminative stimulus effect) are similar to those effects of typical dependence-producing drugs (generalization test).
Physical dependence
- Physical dependence studies (rats and rhesus monkeys)
The physical dependence-producing potential of a test article is investigated by observing the presence/absence of withdrawal symptoms and their intensity, following repeated administration to rats or rhesus monkeys.
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