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- Marshall, S F, et al.
(författare)
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Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims
- 2013
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Ingår i: CPT. - : Wiley. - 2163-8306. ; 2, s. e27-
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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