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Concentration-Response Model of Immediate Release Oxycodone Drug Liking by Different Routes of Abuse.

Autor: Nallani SC; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Li W; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.; Current affiliation: Hefei University of Technology A-Level Center, Hefei, Anhui, China., Calderon SN; Controlled Substance Staff, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Fields E; Current affiliation: Hertz and Fields Consulting, Inc., Silver Spring, Maryland, USA.; Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Roca RA; Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Xu Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Sahajwalla CG; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Zineh I; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Pain medicine (Malden, Mass.) [Pain Med] 2022 Jul 01; Vol. 23 (7), pp. 1311-1322.

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

Autor: Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA., Li Z; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA., Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA., Kim MJ; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA., Nallani SC; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Sahajwalla CG; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Calderon SN; Controlled Substance Staff, Controlled Substance Program, Office of the Center Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Roca RA; Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA., Feng K; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA., Zineh I; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Lionberger R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.

Publikováno v: EClinicalMedicine [EClinicalMedicine] 2021 Sep 16; Vol. 41, pp. 101135. Date of Electronic Publication: 2021 Sep 16 (Print Publication: 2021).

Drug-Drug Interaction Studies of Methadone and Antiviral Drugs: Lessons Learned.

Autor: Younis IR; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Current affiliation: Astellas Pharma Global Development, Inc, Northbrook, IL, USA., Lakota EA; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.; Intitute for Clinical Pharmacodynamics, Schenectady, NY, USA., Volpe DA; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Patel V; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Xu Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Sahajwalla CG; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Publikováno v: Journal of clinical pharmacology [J Clin Pharmacol] 2019 Aug; Vol. 59 (8), pp. 1035-1043. Date of Electronic Publication: 2019 Apr 11.