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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...
Autores principales: | Zhao, Liang, Li, Zhichuan, Fang, Lanyan, Kim, Myong-Jin, Nallani, Srikanth C., Sahajwalla, Chandrahas G., Calderon, Silvia N., Roca, Rigoberto A., Feng, Kairui, Zineh, Issam, Lionberger, Robert |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8455721/ https://www.ncbi.nlm.nih.gov/pubmed/34585126 http://dx.doi.org/10.1016/j.eclinm.2021.101135 |
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