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Page 1
Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency.
Ayalew K, Ning YM, Foringer MJ, Leibenhaut S, Sellers JW, Yu B, Kronstein PD, Higgerson A, Mihaescu C, Rodriguez M, Williams L, Khin NA. Ayalew K, et al. Among authors: kronstein pd. Ther Innov Regul Sci. 2023 Jan;57(1):79-85. doi: 10.1007/s43441-022-00441-w. Epub 2022 Aug 16. Ther Innov Regul Sci. 2023. PMID: 35972722 Free PMC article.
Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.
Sellers JW, Mihaescu CM, Ayalew K, Kronstein PD, Yu B, Ning YM, Rodriguez M, Williams L, Khin NA. Sellers JW, et al. Among authors: kronstein pd. Ther Innov Regul Sci. 2022 Sep;56(5):765-766. doi: 10.1007/s43441-022-00423-y. Ther Innov Regul Sci. 2022. PMID: 35637424 Free PMC article. No abstract available.
Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop.
Khin NA, Francis G, Mulinde J, Grandinetti C, Skeete R, Yu B, Ayalew K, Cho SJ, Fisher A, Kleppinger C, Ayala R, Bonapace C, Dasgupta A, Kronstein PD, Vinter S. Khin NA, et al. Among authors: kronstein pd. Clin Pharmacol Ther. 2020 Nov;108(5):949-963. doi: 10.1002/cpt.1794. Epub 2020 Mar 28. Clin Pharmacol Ther. 2020. PMID: 31958142
Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
Khin NA, Grandinetti C, Dixey H, Yu B, Skeete R, Ayalew K, Budwal-Jagait M, Cho SJ, Dasgupta A, Fisher A, Kleppinger C, Kronstein PD, Martin J, McGuinness M, Mulinde J, Vinter S, Wakelin-Smith J, Walker P, Francis G. Khin NA, et al. Among authors: kronstein pd. Clin Pharmacol Ther. 2022 Jul;112(1):31-43. doi: 10.1002/cpt.2386. Epub 2021 Aug 30. Clin Pharmacol Ther. 2022. PMID: 34358334
A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression.
Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. Diazgranados N, et al. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90. Arch Gen Psychiatry. 2010. PMID: 20679587 Free PMC article. Clinical Trial.
Course of improvement in depressive symptoms to a single intravenous infusion of ketamine vs add-on riluzole: results from a 4-week, double-blind, placebo-controlled study.
Ibrahim L, Diazgranados N, Franco-Chaves J, Brutsche N, Henter ID, Kronstein P, Moaddel R, Wainer I, Luckenbaugh DA, Manji HK, Zarate CA Jr. Ibrahim L, et al. Neuropsychopharmacology. 2012 May;37(6):1526-33. doi: 10.1038/npp.2011.338. Epub 2012 Feb 1. Neuropsychopharmacology. 2012. PMID: 22298121 Free PMC article. Clinical Trial.