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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Detalles Bibliográficos
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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Research Paper
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

Internet

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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