Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 3
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37TABLE OF CONTENTS
I.
INTRODUCTION.......................................................................................................................... 1
II.
BACKGROUND ............................................................................................................................ 2
A. Scope of Guidance ............................................................................................................. 2
B. Definitions .......................................................................................................................... 4
III.
ASSESSING THE ABUSE POTENTIAL OF A DRUG ............................................................ 5
A. Key Decision Points and Recommended Studies in Assessing Abuse Potential .......... 5
B. When Abuse-Related Studies Should Be Conducted ..................................................... 7
C. Preparing the NDA Submission ....................................................................................... 8
D. NDA Review and Product Labeling Related to Abuse Potential .................................. 9
E. The Drug Scheduling Process ........................................................................................ 10
IV.
ABUSE-RELATED DATA FROM CHEMISTRY AND NONCLINICAL STUDIES ......... 11
A. Chemistry and Manufacturing ...................................................................................... 12
B. Screening with Receptor-Ligand Binding Studies ....................................................... 13
C. Use of Nonclinical Pharmacokinetic Data in Animal Abuse-Related Studies ........... 14
D. Animal Abuse-Related Behavioral Pharmacology Studies ......................................... 14
V.
ABUSE-RELATED DATA FROM HUMAN STUDIES ......................................................... 20
A. Use of Clinical Pharmacokinetic Data in Human Abuse-Related Studies ................ 20
B. Abuse-Related Adverse Events in Clinical Safety and Efficacy Studies .................... 21
C. Human Abuse Potential Study in Recreational Drug Users ....................................... 23
D. Clinical Studies That Evaluate Cognition and Performance ...................................... 30
E. Clinical Evaluation of Physical Dependence ................................................................ 30
VI.
POST-MARKETING AND ILLICIT DRUG ABUSE DATA ................................................. 32
ABBREVIATIONS ................................................................................................................................... 34
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