Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 11
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37Contains Nonbinding Recommendations
C. Preparing the NDA Submission
The content of an abuse potential section of an NDA typically includes (or cross-references)
complete study protocols and all primary abuse-related data from the following:
1. Chemistry studies
2. Receptor-ligand binding studies and functional (second messenger) studies
3. Pharmacokinetic studies in animals and humans
4. Abuse–related studies in animals:
a) General behavioral observations from safety pharmacology studies
b) Drug discrimination study
c) Self-administration study
d) Physical dependence study
5. Abuse-related studies in humans:
a) Human abuse potential (HAP) study
b) Physical dependence study
6. Abuse-related AEs from clinical studies
7. Information related to overdose, both intentional and accidental, during clinical
studies
8. Assessment of the incidence of abuse during clinical studies
The abuse potential section of the NDA should also include (or cross-reference) the Integrated
Summary of Safety (ISS), as well as data reflecting abuse of the drug substance contained in the
new drug (or similar drugs) in the form of an approved drug product or as an illicit substance.
Abuse-related studies and data should be submitted in the electronic common technical
document (eCTD) as follows:
• The proposal and rationale related to drug scheduling should be placed in Module 1, tab
1.14.1.
• A summary of all abuse-related animal and human data, discussion of these data, and
conclusions about the drug’s abuse potential should be placed in Module 2. This should
occur as a subsection under tab 2.7.4 Summary of Clinical Safety, and should have
cross-linking to the proposal for scheduling and product labeling in Module 1, as well as
to all abuse-related studies and data in Modules 3, 4, and 5.
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