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Dose Selection Incorporating PK/PD Information in Early Phase Clinical Trials.

Date: 
Monday 15th August 2011 - 16:35 to 17:15
Venue: 
INI Seminar Room 2
Session Title: 
Early phase model-based design
Session Chair: 
Peter Mueller
Abstract: 
Early phase clinical trials generate information on pharmacokinetic parameters and on safety issues. In addition, a dose level, or a set of dose levels, needs to be selected for further examination in later phases. If patients, rather than healthy volunteers, take part in the early phase, it may be possible to observe the effects of the drug on the disease. In the presentation we will discuss some statistical, ethical and economic aspects of designing optimum adaptive clinical trials for dose selection incorporating both pharmacokinetic and pharmacodynamic endpoints.
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Presentation Material: 
University of Cambridge Research Councils UK
    Clay Mathematics Institute London Mathematical Society NM Rothschild and Sons