{"id":61,"date":"2022-07-28T10:53:37","date_gmt":"2022-07-28T09:53:37","guid":{"rendered":"https:\/\/signalmansafety.com\/?page_id=61"},"modified":"2025-08-11T11:09:26","modified_gmt":"2025-08-11T10:09:26","slug":"bibliography","status":"publish","type":"page","link":"https:\/\/signalmansafety.com\/?page_id=61","title":{"rendered":"Bibliography"},"content":{"rendered":"

Artificial Intelligence in Pharmacovigilance Signal Management: A Review of Tools, Implementations, Research, and Regulatory Landscape
\nMaria Antonietta Barbieri, Vera Battini, Carla Carnovale, Marianna Cocco, Despoina Georgia Papoutsi, Nicole Sonne Heckmann, Guojun Dong, Andrea Rossi, Simay Peker, Robbert P Van Manen, Sameer Thapar, Maurizio Sessa
\nExpert Opinion on Drug Safety, 8 August 2025
\nhttps:\/\/doi.org\/10.1080\/14740338.2025.2545926<\/a><\/span><\/span><\/p>\n

Exploring the potential relationship between antineoplastic agents and their association with stomatitis and oral candidiasis in cancer patients
\nAli Amanati, Robbert Van Manen, Laleh Mahmoudi, Hafez Shojaadini, Seyed Reza Abdipour Mehrian, Mohadese Boroughani
\nJournal of Oncology Pharmacy Practice, July 2025
\nhttps:\/\/doi.org\/10.1177\/10781552251354840<\/a><\/span><\/span><\/p>\n

Antineoplastic agents associated with neutropenic enterocolitis in patients with malignancy: A quantitative safety signal analysis
\nAli Amanati, Robbert Van Manen, Sarvin Sajedianfard, Hafez Shojaadini, Mohadese Boroughani, Hossein Molavi Vardanjani
\nJournal of Oncology Pharmacy Practice, March 2024
\nhttps:\/\/journals.sagepub.com\/doi\/full\/10.1177\/10781552241238195<\/span><\/span><\/a><\/span><\/span><\/p>\n

The Potential Antidepressant Effects of Hypoglycaemic Agents: New insights from an analysis of the reporting system databases FAERS & VIGIBASE
\nVera Battini, Robbert P van Manen, Michele Gringeri, Giulia Mosini, Greta Guarnieri, Anna Bombelli, Marco Pozzi, Maria Nobile, Sonia Radice, Emilio Clementi, Carla Carnovale
\nFrontiers in Pharmacology 14:1128387
\nhttps:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2023.1128387\/full<\/a><\/span><\/span><\/p>\n

The Antidepressant Effects of Hypoglycaemic Agents: New insights from an analysis of the reporting system databases FAERS & VIGIBASE
\nCarla Carnovale, Vera Battini, Michele Gringeri, Giulia Mosini, Greta Guarnieri, Sonia Radice, Emilio Clementi,\u00a0Robbert P van Manen
\nISoP 21st Annual Meeting, Verona, Italy \u00b7 September 22, 2022<\/span><\/span><\/p>\n

Rave Harpaz, William DuMouchel, Robbert van Manen, Alexander Nip, Steve Bright, Ana Szarfman, Joseph Tonning, Magnus Lerch
\nSignaling COVID-19 Vaccine Adverse Events
\nDrug Safety, May 8,2020
\nhttps:\/\/rdcu.be\/cQhDH<\/span><\/span><\/a>
\nhttps:\/\/doi.org\/10.1007\/s40264-022-01186-z<\/span><\/span><\/a><\/span><\/span><\/p>\n

Faizan Mazhar, Vera Battini, Michele Gringeri, Marco Pozzi, Giulia Mosini, Albaraa Mohammed N. Marran, Shahzad Akram, Robbert P. van Manen, Sonia Radice, Emilio Clementi, Carla Carnovale
\nThe impact of anti-TNF\u03b1 agents on weight-related changes: new insights from a Real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database
\nExpert Opinion on Biological Therapy, June 30, 2021
\nhttps:\/\/www.tandfonline.com\/doi\/full\/10.1080\/14712598.2021.1948529<\/a><\/span><\/span><\/p>\n

Amanati, A., Lotfi, M., Van Manen, R., Faghihi, M.A., Yavarian, M., Zekavat, O., Badiee, P., Mazinani, N.H. and Bozorgi, H.
\nPotential voriconazole associated posterior reversible leukoencephalopathy in children with malignancies: Report of two cases
\nJournal of Oncology Pharmacy Practice, <\/span>July 20, 2020<\/span><\/span>
\nhttps:\/\/journals.sagepub.com\/doi\/10.1177\/1078155220941590<\/span><\/a><\/span><\/p>\n

Juba, K.M., Van Manen, R.P. and Fellows, S.E.
\nA Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol Related Hypoglycemia
\nAnnals of Pharmacotherapy, Vol 54 (3): 247-253 (2020)<\/span>
\nhttps:\/\/journals.sagepub.com\/eprint\/HNQB9RDZ597KMGPI2CR7\/full<\/a><\/span><\/span>
\nhttps:\/\/doi.org\/10.1177\/1060028019885643<\/span><\/a><\/span><\/span><\/p>\n

Nathan, K.T., Conn, K.M., Van Manen, R.P. and Brown, J.E.
\nSignal detection for bleeding associated with the use of direct oral anticoagulants
\nAmerican Journal of Health-System Pharmacy, Vol. 75(13): 973-977 (2018)<\/span>
\nhttp:\/\/www.ajhp.org\/content\/early\/2018\/05\/04\/ajhp170529?sso-checked=true<\/span><\/span><\/a>
\nhttps:\/\/doi.org\/10.2146\/ajhp170529<\/span><\/a><\/span><\/p>\n

Nagel, A.K., Ahmed-Sarwar, N., Werner, P.M., Cipriano, G.C., Van Manen, R.P. and Brown, J.E.
\nDipeptidyl Peptidase-4 Inhibitor Associated Pancreatic Carcinoma: A Review of the FAERS Database<\/span>
\nAnnals of Pharmacotherapy, Vol. 50(1): 27\u201331 (2016)<\/span>
\nhttps:\/\/journals.sagepub.com\/doi\/abs\/10.1177\/1060028015610123?journalCode=aopd<\/a><\/span><\/span>
\nhttps:\/\/doi.org\/10.1177\/1060028015610123<\/span><\/a><\/span><\/p>\n

Tina M. Khadem, Robbert P. van Manen, Jack Brown
\nHow safe are recently FDA-approved antimicrobials?
\nA review of the FDA adverse event reporting system database
\nPharmacotherapy, Vol. 34(12): 1324-1329 (2014)<\/span>
\nhttp:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/phar.1519\/abstract<\/span><\/a><\/span>
\nhttps:\/\/doi.org\/10.1002\/phar.1519<\/span><\/a><\/span><\/span><\/p>\n

Emmanuel Okon, Christian Engell, Robbert P. van Manen, Jack Brown
\nTigecycline-Related Pancreatitis: A Review of Spontaneous Adverse Events Reports
\nPharmacotherapy, Vol 33(1): 63-8 (2013)
\nhttp:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23307547<\/a><\/span><\/span>
\nhttps:\/\/accpjournals.onlinelibrary.wiley.com\/doi\/abs\/10.1002\/phar.1159<\/a><\/span><\/span><\/p>\n

Robbert P. van Manen
\nManaging Potential Safety Signals Detected Through Quantitative Methods
\nDrug Information Association Global Forum, Vol 3\/4: 21-26 (August 2011)<\/span>
\nhttp:\/\/www.diahome.org\/Tools\/Content.aspx?type=eopdf&file=%2fproductfiles%2f19794%2fgf_16%2Epdf<\/span><\/a><\/span><\/span><\/p>\n

Jack Brown, Samuel L. Aitken and Robbert P. van Manen
\nPotential for Linezolid Associated Blindness: A Review of Spontaneous Adverse Event Reports
\nPharmacotherapy, Vol 31(6): 585-590 (2011)<\/span>
\nhttp:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21923442<\/span><\/a><\/span><\/span>
\nPMID: 21923442 DOI: 10.1592\/phco.31.6.585<\/span><\/p>\n

Mirza I. Rahman and Robbert P. van Manen
\nData Mining
\nIn: Principles and Practice of Pharmaceutical Medicine, 3rd<\/span><\/sup> Edition (Chapter 44)
\nWiley-Blackwell (December 2010)<\/span>
\nhttp:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/9781444325263.ch44\/summary<\/span><\/a><\/span><\/p>\n

Robbert P. van Manen, William DuMouchel and David Fram
\nSignal Detection Methodologies to Support Effective Safety Management
\nExpert Opinion on Drug Safety, Vol. 6\/4, 451-464 (2007)<\/span>
\nhttp:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17688389<\/a><\/span><\/span>
\nhttps:\/\/www.tandfonline.com\/doi\/full\/10.1517\/14740338.6.4.451<\/a><\/span><\/span><\/p>\n

Wayne R. Kubick and Robbert P. van Manen
\nDrug Safety Profiling Goes High Tech
\nBioExecutive International, Vol. 3\/4, 50-53 (2007)<\/span><\/p>\n

Robbert P. van Manen
\nTuning in to Signal Detection
\nGood Clinical Practice Journal, Vol. 12\/8, 9-12 (2005)<\/span><\/p>\n

Robbert P. van Manen
\nSafety Fast!
\nImpact of New Technologies in Safety and Product Issue Tracking and Reporting
\nGood Clinical Practice Journal, Vol. 11\/5, 21-23 (2004)<\/span><\/p>\n

Robbert P. van Manen
\nSafety express: Moving regulatory affairs into the electronic age
\nEuropean Regulatory Affairs News, Vol. 148, 8-9 (2004)<\/span><\/p>\n

Eli Hauser, Lisa Frank and Robbert P. van Manen
\nEngaging technology for safety reporting
\nPharmaceutical Visions, 38-42 (2002)<\/span><\/p>\n

Robbert P. van Manen
\nAn Integrated Approach to Adverse Event Data Management
\nDrug Information Journal, Vol. 30\/3 (1996)<\/span>
\nhttp:\/\/dij.sagepub.com\/content\/30\/3\/731.short<\/span><\/a><\/span><\/p>\n

Robbert P. van Manen and Erik Houthoff
\nA Central Database with Distributed Off-line Data Entry and Correction:
\nThe Best of Both Worlds?
\nDrug Information Journal, Vol. 27\/3 (1993)<\/span>
\nhttp:\/\/dij.sagepub.com\/content\/27\/4\/957.short<\/span><\/a><\/span><\/span><\/p>\n

Robbert P. van Manen and Karel J. de Neef
\nValidating a Clinical Data System:
\nTechnical, Organizational and Managerial Aspects
\nDrug Information Journal, Vol. 27\/2 (1993)<\/span>
\nhttp:\/\/dij.sagepub.com\/content\/27\/2\/245.short<\/span><\/a><\/span><\/span><\/p>\n

W. de Priester, R.P. van Manen and D.L. Knook
\nLysosomal Activity in Ageing Rat Liver II:
\nMorphometry of Acid Phosphatase Positive Dense Bodies
\nMechanisms of Ageing and Development, Vol. 26, 205-216 (1984)<\/span>
\nhttp:\/\/www.sciencedirect.com\/science\/article\/pii\/0047637484900940<\/span><\/a><\/span><\/span><\/p>\n

R.P. van Manen, W. de Priester and D.L. Knook
\nLysosomal Activity in Ageing Rat Liver I:
\nVariation in Enzyme Activity within the Liver Lobule
\nMechanisms of Ageing and Development, Vol. 22, 159-165 (1983)<\/span>
\nhttp:\/\/www.sciencedirect.com\/science\/article\/pii\/0047637483901094<\/span><\/a><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Artificial Intelligence in Pharmacovigilance Signal Management: A Review of Tools, Implementations, Research, and Regulatory Landscape Maria Antonietta Barbieri, Vera Battini, Carla Carnovale, Marianna Cocco, Despoina Georgia Papoutsi, Nicole Sonne Heckmann, Guojun Dong, Andrea Rossi, Simay Peker, Robbert P Van Manen, Sameer Thapar, Maurizio Sessa Expert Opinion on Drug Safety, 8 August 2025 https:\/\/doi.org\/10.1080\/14740338.2025.2545926 Exploring the […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-61","page","type-page","status-publish","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t