Setting Acceptance Limits – Equivalence Limits for Assessing Similarity as an Example
View Presentation *Walter W. Hauck, US Pharmacopeia Keywords: equivalence limits In its general chapters Design and Development of Biological Assays <1032>, Validation of Biological Assays <1033>, and Analysis of Biological Assays <1034>, the US Pharmacopeia proposes an equivalence testing approach for many applications. As with any equivalence test, the most difficult component is the setting of the equivalence limits. This talk will review the various approaches to setting these limits for the problem of assessing similarity (parallelism), with discussion of more general application.
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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