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Page 1
Good Signal Detection Practices: Evidence from IMI PROTECT.
Wisniewski AF, Bate A, Bousquet C, Brueckner A, Candore G, Juhlin K, Macia-Martinez MA, Manlik K, Quarcoo N, Seabroke S, Slattery J, Southworth H, Thakrar B, Tregunno P, Van Holle L, Kayser M, Norén GN. Wisniewski AF, et al. Among authors: manlik k. Drug Saf. 2016 Jun;39(6):469-90. doi: 10.1007/s40264-016-0405-1. Drug Saf. 2016. PMID: 26951233 Free PMC article.
Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment.
Wang L, Golchin N, Klot SV, Salinas CA, Manlik K, Patadia V, Miller MK, Asubonteng J, McDermott R, Barberio J, Gipson G. Wang L, et al. Among authors: manlik k. Ther Innov Regul Sci. 2024 Nov;58(6):1014-1022. doi: 10.1007/s43441-024-00694-7. Epub 2024 Sep 6. Ther Innov Regul Sci. 2024. PMID: 39242460 Free PMC article.
Leveraging Real-World Data in Safety Signal Assessment.
Patadia V, Manlik K, Gipson G, Willis JC, Namuyinga R, McDermott R, Shaw A, Miller MK, Asubonteng J, Golchin N, von Klot S. Patadia V, et al. Among authors: manlik k. Ther Innov Regul Sci. 2024 Nov;58(6):1062-1070. doi: 10.1007/s43441-024-00682-x. Epub 2024 Aug 6. Ther Innov Regul Sci. 2024. PMID: 39105929 Free PMC article.
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration.
Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G, Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M, Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ, Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E, Raschi E, Khouri C. Fusaroli M, et al. Among authors: manlik k. Drug Saf. 2024 Jun;47(6):585-599. doi: 10.1007/s40264-024-01423-7. Epub 2024 May 7. Drug Saf. 2024. PMID: 38713347 Free PMC article.
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement.
Fusaroli M, Salvo F, Begaud B, AlShammari TM, Bate A, Battini V, Brueckner A, Candore G, Carnovale C, Crisafulli S, Cutroneo PM, Dolladille C, Drici MD, Faillie JL, Goldman A, Hauben M, Herdeiro MT, Mahaux O, Manlik K, Montastruc F, Noguchi Y, Norén GN, Noseda R, Onakpoya IJ, Pariente A, Poluzzi E, Salem M, Sartori D, Trinh NTH, Tuccori M, van Hunsel F, van Puijenbroek E, Raschi E, Khouri C. Fusaroli M, et al. Among authors: manlik k. Drug Saf. 2024 Jun;47(6):575-584. doi: 10.1007/s40264-024-01421-9. Epub 2024 May 7. Drug Saf. 2024. PMID: 38713346 Free PMC article.