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Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. (Pharmacometrics)
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2013 (English)In: CPT: pharmacometrics & systems pharmacology, ISSN 2163-8306, Vol. 2, e27- p.Article in journal (Refereed) Published
Abstract [en]

The role of modeling and simulation (M&S) in the design and interpretation of phase III studies, from break out session 4 of the European Medicines Agency (EMA)/European Federation of Pharmaceutical Industries and Associations (EFPIA) M&S workshop, was divided into themes illustrated with case studies (Table 1): (1) M&S being conducted to support the design of confirmatory trials; (2) longitudinal model-based test as primary inferential analysis (biosimilarity and disease progression trials); (3) assessment of benefit–risk ratio, approval and labeling of an unstudied dose or dosing regimen, and development of future regulatory guidance.

Place, publisher, year, edition, pages
2013. Vol. 2, e27- p.
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Pharmaceutical Sciences
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URN: urn:nbn:se:uu:diva-221603DOI: 10.1038/psp.2013.4PubMedID: 23835938OAI: oai:DiVA.org:uu-221603DiVA: diva2:709703
Available from: 2014-04-02 Created: 2014-04-02 Last updated: 2014-09-24Bibliographically approved

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Karlsson, M O

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