The impact of outlying subjects on decision of bioequivalence.
As a consequence of a hearing on bioequivalence conducted by the Food and Drug Administration in 1986, the identification and the treatment of a potential outlier in bioequivalence trials has become an important issue in the assessment of bioequivalence because the exclusion of a statistically identified outlier may lead to a totally different conclusion on bioequivalence. In this paper, we examine the impact of a statistically identified outlying subject on the decision of bioequivalence through a simulation study under the structure of a standard two-way crossover design based on interval hypotheses for bioequivalence. The Hotelling T2 test suggested by Liu and Weng (1) is used for detection of an outlying subject.
Ki
F Y
FY
Biostatistics and Data Management Department, Bristol-Myers Squibb Company, Plainsboro, New Jersey 08536, USA.
Liu
J P
JP
Wang
W
W
Chow
S C
SC
D018592:Cross-Over Studies; D006801:Humans; D010599:Pharmacokinetics; D013223:Statistics as Topic / Q000379:methods*; D013810:Therapeutic Equivalency