The Challenges of Achieving Clinically Relevant CM&C Specifications
View Presentation *Jeffrey D Hofer, Eli Lilly and Company Keywords: specifications, acceptance criteria, bioequivalence The linkage of acceptance criteria to clinical relevance is a key facet in the new risk-based initiative. While it is easy to express a desire to establish such a linkage, it is nevertheless quite challenging to actually do so. Recently, the importance of the clinical relevance of acceptance criteria used in relationship to risk assessments has become more recognized. Some of the technical and pragmatic challenges of achieving CM&C specifications directly linked to product fitness for use will be discussed related to bioequivalence requirements and clinical dose response curves. This talk will highlight the fact that the current interpretation of acceptance criteria, which focuses on individual test results, is not consistent with a clinically relevant framework as opposed to an alternative interpretation of acceptance criteria as referring to batch parameters.
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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