A table titled "Table 1: Draft Guidance for Industry: Abuse-Deterrent opioid Evaluation and Labeling US Department of Health and Human Services Food and Drug Administration and Center for Drug Evaluation and Research January 2013". The table is divided into four sections. The first section is titled "The 4 Tiers of Claims That Describe the Potential Abuse-detergent Properties". It explains that the table is a draft guidance for industry abuse-deterrent opioid evaluation and labeling which is a tool used to assess the effectiveness of drug evaluation and research in the United States. The table has three tiers - Tier 1 Tier 2 and Tier 3. The first tier is labeled "Formulated with physicochemical barriers to abuse" and the second tier is labelled "Specific properties that resist manipulation and/or the result of the release of compo-nets". The third tier is listed as "Pharmacokinetic data may be used to demonstrate abuse deterrence". At the bottom of the table there is a section titled "Data from human abuse potential studies may demonstrate a significant degree of reduction in drug-related potential". This section discusses the potential abuse deterrent properties and how they can be used in the study.

Category
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Date
2014
Collection
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