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2006D-0088
C 4
Volume 3

Comment

Reference 1 - Chaloupka A, et al. Comparative Analysis of Six European Influenza Vaccines. European Journal of Clinical Microbiology and Infectious Diseases 1996; 15: 121-127. Published Material

Reference 2 - Julious SA. Tutorial in Biostatistics: Sample Sizes for Clinical Trials with Normal Dara. Statistics in Medicine 2004; 23: 1921-1986(Section 4.1). Published Material

Reference 3 - Nauta J. Statistical Analysis of Influenza Vaccine Lot Consistency Studies, Review Paper to Appear in the Journal of Biopharmaceutical Statistics (2006).

Reference 4 - CPMP/BWP. Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96), 12 March 1997. [http://www.emea.eu.int/pdfs/human/bwp/021496en.pdf]

Reference 5 - Nauta J. and Debruijn I. The European CHMP Criteria for Influenza Vaccine Immunogenicity Cannot be Improved by the Use of Confidence Intervals. Second European Influenza Conference (Malta 11-14 September 2005).

Reference 6 - Senn S. Added Values. Controversies Concerning Randomization and Additivity in Clinical Trials. Statistics in Medicine 2004; 23: 3729-3753. Published Material


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