Statistical Considerations when Evaluating Content Uniformity
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*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.