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Association of partial systemic exposure and abuse potential for opioid analgesics with abuse deterrence labeling claims supporting product-specific guidance.
Zhao L, Li Z, Fang L, Kim MJ, Nallani SC, Sahajwalla CG, Calderon SN, Roca RA, Feng K, Zineh I, Lionberger R. Zhao L, et al. Among authors: zineh i. EClinicalMedicine. 2021 Sep 16;41:101135. doi: 10.1016/j.eclinm.2021.101135. eCollection 2021 Nov. EClinicalMedicine. 2021. PMID: 34585126 Free PMC article.
Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting.
Sahre MD, Milligan L, Madabushi R, Graham RA, Reynolds KS, Terzic A, Benjamin J, Burckart GJ, Huang SM, Schuck R, Thompson AM, Zineh I. Sahre MD, et al. Among authors: zineh i. Clin Pharmacol Ther. 2021 Aug;110(2):285-288. doi: 10.1002/cpt.2151. Epub 2021 Feb 16. Clin Pharmacol Ther. 2021. PMID: 33411946
141 results