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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Statistical Review

Date August 15, 2007
To Katherine Berkhousen
Rakesh Pandey
From Lev A. Sirota
Vaccines Evaluation Branch
Through A. Dale Horne
Branch Chief
Subject: BLA 125254 (CSL Ltd ACN)
Influenza Virus Vaccine
c.c. Chronological File
Dale Horne
Henry Hsu
Lev A. Sirota
Steve Anderson

Background

I was asked to review statistical reasoning and calculations supporting validation of the ---------------------------
--------------------------------------test in this submission. My comments are in italics

Summary Statement

I did not find major bioassay-related statistical issues that may prevent this submission from being approved.

Results and Comments to CBER

In the -------- test validation, the sponsor used a standard set of validation parameters: accuracy, specificity, sensitivity, precision, and linearity (Module 5 Vol. 29 Section 5.3.5.5-1, p. 3).

Accuracy has been evaluated ---------------------------------------------------------------------------------------

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3


PAGE(S)


DETERMINED


TO BE


NOT RELEASABLE


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