Using Fitness-for-Use to Define Design Space for Analytical Methods
View Presentation Bruno Boulanger, Arlenda S.A. *Pierre Lebrun, University of Liège Keywords: Design Space, Fitness-for-use, Optimization, Prediction, Bayesian model, Specifications A framework to identify Design Space (DS) will be presented based on Bayesian modeling. The ways to conceive and apply this methodology to bioassays will be shown. Through a Ligand-Binding Assay (LBA) example, the use of Bayesian modeling for the development of a robust optimal assay will be illustrated, with the relationship to the specifications applying on the precision of measurements and the dosing range. The ways to derive the predictive precision profile and to identify the set of conditions that guarantee the future results within the specifications will be examined. From these perspectives, predictions and specifications are the keys to define the DS for an analytical procedure. The similarities of the DS derived from assay optimization and the DS used in the validation phase will be highlighted. Finally, the ways to define acceptance limits for future runs will also be shown.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC