Online Program Home
My Program

Abstract Details

Activity Number: 39
Type: Contributed
Date/Time: Sunday, July 31, 2016 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #318760 View Presentation
Title: Dependence Liability Study Using Healthy Subjects
Author(s): Ling Chen*
Companies: FDA/CDER
Keywords: Dependence liability ; Healthy subjects ; Physical dependence ; Withdrawal syndrowme
Abstract:

Physical dependence is often characterized by withdrawal symptoms and can be assessed by evaluating repeated doses over a sufficient period of time, followed by abrupt discontinuation. For all drugs being considered for scheduling in Schedule II, III, IV and V, an assessment of relative dependence liability is required. Dependence should be considered a general safety issue that should be assessed even in drugs that are not CNS-active or being considered for scheduling. In case where dependence has not been considered safe to study or where it is not ethical for patient treatment reasons, the assessment has been relied on animal data. If there is no ethical issue, dependence liability study can also be conducted by using healthy subjects. In this presentation, I will focus on the dependence liability study using healthy subjects, and discuss pros and cons of study designs proposed in recent protocols. If time permits, I will also discuss sample size calculation as well as missing data imputation for these studies.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2016 program

 
 
Copyright © American Statistical Association