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Dear Mr. Nadeem Irfan Bukhari
Your post on 22 Aug 2006 relating to outlier is quiet a help for me, kindly will you let me know the FDA guideline where it is suggested "The outlier be retested in a sample of 6-10 subjects from the original study to support the anomalous nature of the suspected outlier"
I need to quote and cite the reference of the FDA guidelines.
Thanking you.
Shakti Tripathy
Regulatory Affairs
Mumbai, India
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Dear Shakti Tripathy
The referred information were based on "Bolton S and Bon C. Pharmaceutical Statistics - practical and clinical applications, Marcel Dekker, INC. 2004"
Truly yours
--
Dr. Nadeem Irfan Bukhari
(PhD Pharm. Tech.)
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