An Assessment on Handling of Outlier Subjects in Bioequivalence Study – A Review
نویسندگان
چکیده
The purpose of this article is to explicate the procedures for detecting outliers subject in bioequivalence study as per as per various regulatory agencies (e.g. USFDA, TPD, ANVISA and CDSCO). The existence of outlier subjects in bioequivalence studies possibly will have an effect on the results of the study. The present article provides the details regarding Studentized Residual Test and Lund Test for identification of outlier subjects in bioequivalence study. This article also represents the view of various drug regulatory agencies about re-testing / redosing of outlier subjects. Accepted : 13 Jan 2014 Published online: 31 Jan 2014
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