Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 20
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37Contains Nonbinding Recommendations
Schedules of Reinforcement for Operant Studies. When animals are first being trained in the
test procedures for self-administration and drug discrimination studies, they typically receive a
reward each time they respond appropriately, corresponding to a fixed ratio 1 (FR1) schedule of
reinforcement. The requirement for the number of correct responses (e.g., lever presses) to
receive a reward is then increased with continued training. However, final testing should be
conducted using a standard FR10, rather than schedules of reinforcement with greater response
requirements (e.g., use of fixed ratio values greater than 10, or use of progressive ratio).
Application of Good Laboratory Practice (GLP). Abuse-related nonclinical studies must be
conducted using GLP, as these are nonclinical laboratory studies conducted to support approval
of a drug for use in humans. See 21 CFR 58.1. Sponsors should refer to the following
guidances, as well as to 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory
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Studies),
to ensure compliance with GLP requirements when conducting abuse-related
nonclinical studies:
• M3(R2) guidance
• ICH guidance for industry, S7A Safety Pharmacology Studies for Human
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Pharmaceuticals (2001).
2.
General Behavioral Tests
Irwin Test. This is a study of general behavior in which animals are observed in an open cage
after acute administration of a test drug over a period of time that covers C
. Observations
max
may include body posture (flat, rearing), grooming, vocalization, mobility, chewing, appearance
and ease of handling. Data from this study can provide initial indications of whether a drug
produces abuse-related effects such as stimulant or sedative properties. This test should be
conducted as part of the toxicology safety battery, so the doses used reflect a broad range of
doses that produce plasma levels that are similar to, as well as greater than or less than, those
produced by the proposed human therapeutic dose. The route of administration often parallels
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Note that 21 CFR 58.10 states, “When a sponsor conducting a nonclinical laboratory study intended to be
submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory,
contractor, or grantee to perform an analysis or other service [such as abuse-related studies], it shall notify the
consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be
conducted in compliance with the provisions of [the regulations in Good Laboratory Practice for Nonclinical
Studies]. See also FDA’s Proposed Rule in the Federal Register (8/24/16), “Good Laboratory Practice for
Nonclinical Laboratory Studies”, available at
https://
19875/good-laboratory-practice-for-nonclinical-laboratory-studies.
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Available at
We
update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs
guidance Web page at
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