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Methylprednisolone-induced hepatotoxicity: experiences from global adverse drug reaction surveillance
Stockholm University, Faculty of Social Sciences, Department of Computer and Systems Sciences. Uppsala Monitoring Centre, Sweden.
2014 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 70, no 4, 501-503 p.Article in journal, Letter (Refereed) Published
Place, publisher, year, edition, pages
2014. Vol. 70, no 4, 501-503 p.
National Category
Pharmacology and Toxicology
URN: urn:nbn:se:su:diva-100282DOI: 10.1007/s00228-013-1632-3ISI: 000332961700017OAI: diva2:692425
Available from: 2014-01-31 Created: 2014-01-31 Last updated: 2015-11-16Bibliographically approved
In thesis
1. Quantitative methods to support drug benefit-risk assessment
Open this publication in new window or tab >>Quantitative methods to support drug benefit-risk assessment
2014 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Joint evaluation of drugs’ beneficial and adverse effects is required in many situations, in particular to inform decisions on initial or sustained marketing of drugs, or to guide the treatment of individual patients. This synthesis, known as benefit-risk assessment, is without doubt important: timely decisions supported by transparent and sound assessments can reduce mortality and morbidity in potentially large groups of patients. At the same time, it can be hugely complex: drug effects are generally disparate in nature and likelihood, and the information that needs to be processed is diverse, uncertain, deficient, or even unavailable. Hence there is a clear need for methods that can reliably and efficiently support the benefit-risk assessment process. For already marketed drugs, this process often starts with the detection of previously unknown risks that are subsequently integrated with all other relevant information for joint analysis.

In this thesis, quantitative methods are devised to support different aspects of drug benefit-risk assessment, and the practical usefulness of these methods is demonstrated in clinically relevant case studies. Shrinkage regression is adapted and implemented for large-scale screening in collections of individual case reports, leading to the discovery of a link between methylprednisolone and hepatotoxicity. This adverse effect is then considered as part of a complete benefit-risk assessment of methylpredniso­lone in multiple sclerosis relapses, set in a general framework of probabilistic decision analysis. Two methods devised in the thesis substantively contribute to this assessment: one for efficient generation of utility distributions for the considered clinical outcomes, driven by modelling of qualitative information; and one for computing risk limits for rare and otherwise non-quantifiable adverse effects, based on collections of individual case reports.

Place, publisher, year, edition, pages
Stockholm: Department of Computer and Systems Sciences, Stockholm University, 2014. 94 p.
Report Series / Department of Computer & Systems Sciences, ISSN 1101-8526 ; 14-001
National Category
Information Systems
Research subject
Computer and Systems Sciences
urn:nbn:se:su:diva-100286 (URN)978-91-7447-856-3 (ISBN)
Public defence
2014-03-21, Sal C, Forum 100, Isafjordsgatan 39, Kista, 10:00 (English)

At the time of the doctoral defence the following papers were unpublished and had a status as follows: Paper 6: Manuscript; Paper 7: Manuscript.

Available from: 2014-02-27 Created: 2014-01-31 Last updated: 2015-11-16Bibliographically approved

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Caster, Ola
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