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 potential relationship between antineoplastic agents and their association with stomatitis and oral candidiasis in cancer patients
Ali Amanati, Robbert Van Manen, Laleh Mahmoudi, Hafez Shojaadini, Seyed Reza Abdipour Mehrian, Mohadese Boroughani
Journal of Oncology Pharmacy Practice, July 2025
https://doi.org/10.1177/10781552251354840
Antineoplastic agents associated with neutropenic enterocolitis in patients with malignancy: A quantitative safety signal analysis
Ali Amanati, Robbert Van Manen, Sarvin Sajedianfard, Hafez Shojaadini, Mohadese Boroughani, Hossein Molavi Vardanjani
Journal of Oncology Pharmacy Practice, March 2024
https://journals.sagepub.com/doi/full/10.1177/10781552241238195
The Potential Antidepressant Effects of Hypoglycaemic Agents: New insights from an analysis of the reporting system databases FAERS & VIGIBASE
Vera Battini, Robbert P van Manen, Michele Gringeri, Giulia Mosini, Greta Guarnieri, Anna Bombelli, Marco Pozzi, Maria Nobile, Sonia Radice, Emilio Clementi, Carla Carnovale
Frontiers in Pharmacology 14:1128387
https://www.frontiersin.org/articles/10.3389/fphar.2023.1128387/full
The Antidepressant Effects of Hypoglycaemic Agents: New insights from an analysis of the reporting system databases FAERS & VIGIBASE
Carla Carnovale, Vera Battini, Michele Gringeri, Giulia Mosini, Greta Guarnieri, Sonia Radice, Emilio Clementi, Robbert P van Manen
ISoP 21st Annual Meeting, Verona, Italy · September 22, 2022
Rave Harpaz, William DuMouchel, Robbert van Manen, Alexander Nip, Steve Bright, Ana Szarfman, Joseph Tonning, Magnus Lerch
Signaling COVID-19 Vaccine Adverse Events
Drug Safety, May 8,2020
https://rdcu.be/cQhDH
https://doi.org/10.1007/s40264-022-01186-z
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
The impact of anti-TNFα agents on weight-related changes: new insights from a Real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database
Expert Opinion on Biological Therapy, June 30, 2021
https://www.tandfonline.com/doi/full/10.1080/14712598.2021.1948529
Amanati, A., Lotfi, M., Van Manen, R., Faghihi, M.A., Yavarian, M., Zekavat, O., Badiee, P., Mazinani, N.H. and Bozorgi, H.
Potential voriconazole associated posterior reversible leukoencephalopathy in children with malignancies: Report of two cases
Journal of Oncology Pharmacy Practice, July 20, 2020
https://journals.sagepub.com/doi/10.1177/1078155220941590
Juba, K.M., Van Manen, R.P. and Fellows, S.E.
A Review of the Food and Drug Administration Adverse Event Reporting System for Tramadol Related Hypoglycemia
Annals of Pharmacotherapy, Vol 54 (3): 247-253 (2020)
https://journals.sagepub.com/eprint/HNQB9RDZ597KMGPI2CR7/full
https://doi.org/10.1177/1060028019885643
Nathan, K.T., Conn, K.M., Van Manen, R.P. and Brown, J.E.
Signal detection for bleeding associated with the use of direct oral anticoagulants
American Journal of Health-System Pharmacy, Vol. 75(13): 973-977 (2018)
http://www.ajhp.org/content/early/2018/05/04/ajhp170529?sso-checked=true
https://doi.org/10.2146/ajhp170529
Nagel, A.K., Ahmed-Sarwar, N., Werner, P.M., Cipriano, G.C., Van Manen, R.P. and Brown, J.E.
Dipeptidyl Peptidase-4 Inhibitor Associated Pancreatic Carcinoma: A Review of the FAERS Database
Annals of Pharmacotherapy, Vol. 50(1): 27–31 (2016)
https://journals.sagepub.com/doi/abs/10.1177/1060028015610123?journalCode=aopd
https://doi.org/10.1177/1060028015610123
Tina M. Khadem, Robbert P. van Manen, Jack Brown
How safe are recently FDA-approved antimicrobials?
A review of the FDA adverse event reporting system database
Pharmacotherapy, Vol. 34(12): 1324-1329 (2014)
http://onlinelibrary.wiley.com/doi/10.1002/phar.1519/abstract
https://doi.org/10.1002/phar.1519
Emmanuel Okon, Christian Engell, Robbert P. van Manen, Jack Brown
Tigecycline-Related Pancreatitis: A Review of Spontaneous Adverse Events Reports
Pharmacotherapy, Vol 33(1): 63-8 (2013)
http://www.ncbi.nlm.nih.gov/pubmed/23307547
https://accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/phar.1159
Robbert P. van Manen
Managing Potential Safety Signals Detected Through Quantitative Methods
Drug Information Association Global Forum, Vol 3/4: 21-26 (August 2011)
http://www.diahome.org/Tools/Content.aspx?type=eopdf&file=%2fproductfiles%2f19794%2fgf_16%2Epdf
Jack Brown, Samuel L. Aitken and Robbert P. van Manen
Potential for Linezolid Associated Blindness: A Review of Spontaneous Adverse Event Reports
Pharmacotherapy, Vol 31(6): 585-590 (2011)
http://www.ncbi.nlm.nih.gov/pubmed/21923442
PMID: 21923442 DOI: 10.1592/phco.31.6.585
Mirza I. Rahman and Robbert P. van Manen
Data Mining
In: Principles and Practice of Pharmaceutical Medicine, 3rd Edition (Chapter 44)
Wiley-Blackwell (December 2010)
http://onlinelibrary.wiley.com/doi/10.1002/9781444325263.ch44/summary
Robbert P. van Manen, William DuMouchel and David Fram
Signal Detection Methodologies to Support Effective Safety Management
Expert Opinion on Drug Safety, Vol. 6/4, 451-464 (2007)
http://www.ncbi.nlm.nih.gov/pubmed/17688389
https://www.tandfonline.com/doi/full/10.1517/14740338.6.4.451
Wayne R. Kubick and Robbert P. van Manen
Drug Safety Profiling Goes High Tech
BioExecutive International, Vol. 3/4, 50-53 (2007)
Robbert P. van Manen
Tuning in to Signal Detection
Good Clinical Practice Journal, Vol. 12/8, 9-12 (2005)
Robbert P. van Manen
Safety Fast!
Impact of New Technologies in Safety and Product Issue Tracking and Reporting
Good Clinical Practice Journal, Vol. 11/5, 21-23 (2004)
Robbert P. van Manen
Safety express: Moving regulatory affairs into the electronic age
European Regulatory Affairs News, Vol. 148, 8-9 (2004)
Eli Hauser, Lisa Frank and Robbert P. van Manen
Engaging technology for safety reporting
Pharmaceutical Visions, 38-42 (2002)
Robbert P. van Manen
An Integrated Approach to Adverse Event Data Management
Drug Information Journal, Vol. 30/3 (1996)
http://dij.sagepub.com/content/30/3/731.short
Robbert P. van Manen and Erik Houthoff
A Central Database with Distributed Off-line Data Entry and Correction:
The Best of Both Worlds?
Drug Information Journal, Vol. 27/3 (1993)
http://dij.sagepub.com/content/27/4/957.short
Robbert P. van Manen and Karel J. de Neef
Validating a Clinical Data System:
Technical, Organizational and Managerial Aspects
Drug Information Journal, Vol. 27/2 (1993)
http://dij.sagepub.com/content/27/2/245.short
W. de Priester, R.P. van Manen and D.L. Knook
Lysosomal Activity in Ageing Rat Liver II:
Morphometry of Acid Phosphatase Positive Dense Bodies
Mechanisms of Ageing and Development, Vol. 26, 205-216 (1984)
http://www.sciencedirect.com/science/article/pii/0047637484900940
R.P. van Manen, W. de Priester and D.L. Knook
Lysosomal Activity in Ageing Rat Liver I:
Variation in Enzyme Activity within the Liver Lobule
Mechanisms of Ageing and Development, Vol. 22, 159-165 (1983)
http://www.sciencedirect.com/science/article/pii/0047637483901094
