Modeling and Simulation to Optimize the Design and Analysis of Confirmatory Trials, Characterize Risk–Benefit, and Support Label Claims

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. CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e27; doi:; advance online publication 27 February 2013

Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

“…There are three principal sections (3)(4)(5) of the document, each of which is targeted towards a distinct, but complementary, audience. The first section provides (company) decision makers an overview as to ''why'' MID3 is important based on current practice and expressed value to-date.…”

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Model-Informed Drug Discovery and Development Strategy for the Rapid Development of Anti-Tuberculosis Drug Combinations

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Regulatory Modeling and Simulation Moves Into the Next Gear in Europe

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