Method of data interpretation for the determination of abuse liability in rodent self-administration studies under the FDA guidance document.
All new molecular entities that enter the CNS and exert an activity in the brain must be assessed for abuse liability prior to a New Drug Application approval by the US Food and Drug Administration. One element of the screening process is the assessment of the reinforcing properties of the drug candidate using the regulatory-preferred species, the rat. We describe one method of data review from the standard rat IV SA study design that can be used to conclude the relative abuse liability of the new drug entity. While we do not claim the process as the only way to review or interpret the data, we believe the steps described highlight a process that the pharmaceutical development team can use as a starting point for a discussion during study protocol development.
Neurobehavioral Sciences Department, MPI Research, Inc., 54943 North Main Street, Mattawan, MI 49071, USA. Electronic address: david.gauvin@mpiresearch.com.
David V
DV
Gauvin
Neurobehavioral Sciences Department, MPI Research, Inc., 54943 North Main Street, Mattawan, MI 49071, USA; Department of Psychology, Western Michigan University, MPI Research Inc., Kalamazoo, 54943 North Main Street, Mattawan, MI 49071, USA. Electronic address: Zachary.zimmermann@mpiresearch.com.
Zachary J
ZJ
Zimmermann
Drug Safety, MPI Research, Inc., 54943 North Main Street, Mattawan, MI 49071, USA. Electronic address: theodore.baird@mpiresearch.com.
Theodore J
TJ
Baird
D000818:Animals; D003216:Conditioning, Operant; D017408:Guidelines as Topic; D051379:Mice; D051381:Rats; D012054:Reinforcement, Psychology; D012377:Rodentia; D012646:Self Administration; D019966:Substance-Related Disorders / Q000523:psychology*; D014481:United States; D014486:United States Food and Drug Administration
Acute reinforcer; Acute tolerance; DEA; Drug control policy; Extinction; FDA; Methods; New drug application; Reinforcement; Self-administration