Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance

Background: Over the past decade, U.S. FDA has approved 10 opioid analgesics in abuse-deterrent formulations (ADFs). ADFs are intended to reduce abuse of a prescription opioid through manipulation of the product to use one or more routes of abuse. Although it is critically needed for evaluation of t...

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Bibliographic Details
Main Authors: Liang Zhao, Zhichuan Li, Lanyan Fang, Myong-Jin Kim, Srikanth C. Nallani, Chandrahas G. Sahajwalla, Silvia N. Calderon, Rigoberto A. Roca, Kairui Feng, Issam Zineh, Robert Lionberger
Format: Article
Language:English
Published: Elsevier 2021-11-01
Series:EClinicalMedicine
Subjects:
Opioid analgesics
Abuse potential
Partial AUC
Drug Liking Visual Analogue Scale (VAS)
Take Drug Again VAS
Online Access:http://www.sciencedirect.com/science/article/pii/S2589537021004156

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http://www.sciencedirect.com/science/article/pii/S2589537021004156

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