A Bayesian Approach to the ICH Q8 Definition of Design Space
View Presentation *John Joseph Peterson, GlaxoSmithKline Pharmaceuticals Keywords: multivariate regression, prior information, response surface methodology The ICH Q8 FDA Guidance for Industry defines "Design Space" as: "The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality." Working within the design space is not considered as a change, and hence needed modifications within the design space can be made without formal regulatory approval. As such, construction of a design space for pharmaceutical development is important. The talk presents a flexible Bayesian approach to constructing a design space based upon the concepts in Peterson (2004).
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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