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- Title
Striving for Consensus on Approaches to Category 1 Testing of Abuse-Deterrent Formulations of Opioids: Discussions from the First Category 1 Focus Group Meeting.
- Authors
Cone, Edward J.; Sokolowska, Marta; Lindhardt, Karsten
- Abstract
The article discusses the highlights of the discussions from the First Category 1 Focus Group Meeting regarding the testing of abuse-deterrent (AD) formulations of opioids. The 2015 Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling" released by the U.S. Food and Drug Administration (FDA) is discussed. Category 1 determines AD characteristics through laboratory-based in vitro manipulation and extraction studies.
- Publication
Pain Practice, 2016, Vol 16, Issue 7, p809
- ISSN
1530-7085
- Publication type
Editorial
- DOI
10.1111/papr.12488