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Potency Release Specifications - Internal Meeting Memo - Rotarix


DATE: March 27, 2008
FROM: Laraine S. Henchal, Microbiologist Reviewer, DVRPA, CBER, Review Committee Chair, STN 125265/0
SUBJECT: Internal meeting to discuss the potency release specifications for STN #125265/0, Rotarix®, Rotavirus Vaccine, Live, Oral from GlaxoSmithKline Biologicals

Following the analysis of the data submitted by GSK on March 21, 2008 in Amendment 29 (see review by Phil Krause and Lev Sirota, dated March 28, 2008 for detailed analysis), the group decided that the potency specification for release of Rotarix vaccine should be ---------------------------------- mean ----- CCID50 and ------------------------------------------CCID50/dose. The end-expiry titer should be not less than mean 106.0 CCID50/dose

CBER participants:

Phil Krause
Dino Feigelstock
Steve Feinstone


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