
Statistical Review - AFLURIA

 

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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