Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 33
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37Contains Nonbinding Recommendations
Secondary Analyses
Secondary analyses should include the secondary subjective measures and objective measures
(such as pupil size) and time to peak effect. The analyses should follow the same procedure as
the primary analyses.
It is important to note that although the abuse-related AEs observed during HAP studies do not
undergo a statistical evaluation, they are still an important component in assessing the abuse
signals produced during the HAP study.
All statistical analyses including primary, secondary, any alternative and supportive analyses
should be pre-specified.
D. Clinical Studies That Evaluate Cognition and Performance
Clinical studies that evaluate cognition and performance can provide additional safety
information regarding the psychoactive effects of drugs that may have abuse potential. If a
sponsor wishes to evaluate these parameters, the testing may occur during a HAP study with
recreational drug users. Alternatively, the testing may occur during separate studies in healthy
individuals who do not have experience with recreational drugs. Cognitive tests include those
that assess the effects of a test drug on memory, perception, attention, language ability, or
consciousness. Performance tests generally evaluate psychomotor abilities such as response time
or amount of sway while standing.
If a test drug interferes with cognition or performance, this does not inherently mean that the
drug has abuse potential, but it does provide important information related to the drug’s CNS
pharmacology. These responses may also suggest ways in which a test drug could endanger the
health or safety of individuals who take the drug (or those around them). Data from these studies
may be useful in predicting public health risks, which is a critical area discussed in the 8FA(see
21 U.S.C. 811(c)(6)).
The ability of a drug to induce changes in cognition or performance may alter the attractiveness
of a drug for abuse purposes. Research regarding methods of assessing whether a particular drug
product has more or less attractiveness to recreational drug users is ongoing. However, for
regulatory purposes, any evaluation of the attractiveness of a drug product should be based on a
method that is scientifically validated and reliable in terms of its ability to predict abuse
potential.
E. Clinical Evaluation of Physical Dependence
An abuse potential assessment should include an evaluation of whether a drug produces physical
dependence, in order to: 1) provide accurate information in labeling regarding the risks
associated with abrupt drug discontinuation (and the possible need for tapered discontinuation),
and 2) provide information that FDA will use in determining whether a drug will be
recommended for scheduling under the CSA, and if so, which schedule should be recommended
(see 21 U.S.C. 811(c)(7)).
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