Statistical Considerations when Evaluating Content Uniformity
View Presentation *James Bergum, Bristol-Myers Squibb Kim E. Vukovinsky, Pfizer Keywords: content uniformity Two issues related to testing for content uniformity are discussed: 1) Large sample lot release criteria to provide “similar” performance to the ICH harmonized UDU test. As a result of non-destructive measurement techniques such as NIR that can provide a large number of content uniformity results, several new large sample tests will be presented and 2) Limits that provide assurance that a future sample taken from a batch will pass the UDU test. A methodology [CuDAL (Content Uniformity and Dissolution Acceptance Limits)] described in ASTM Standard E2709 that provides this assurance 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