A novel bootstrap approach for setting acceptance criteria on potency assay parameters
View Presentation *Daniel Joelsson, Merck & Co. Inc *Yue Wang, Merck & Co. Inc Keywords: potency assay, acceptance criteria, bootstrap, quality control Prior to utilizing assays for release and stability of clinical material, it is required per regulatory expectation and necessary for good scientific practice to establish quality control parameters and the corresponding acceptance criteria. Early in assay development, we often lack a large dataset to establish these criteria by. This is especially true for lower throughput, high variability assays such as bioassays. A bootstrap (random sampling with replacement) based method may be used to establish appropriate acceptance criteria with limited data. In this talk we will evaluate the performance and implementation of such a method. Examples based on real assay data will be presented.
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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